Conditions: Colonoscopy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 91
Healthy volunteers: no

Brief summary:
The objective of this study is to compare the safety, tolerance and efficacy of BLI800 to a PEG based preparation prior to colonoscopy in adolescent patients.

Detailed description:

Arms:
arm 1: BLI800 bowel preparation (high dose) arm 2: BLI800 bowel preparation (low dose) arm 3: PEG based bowel preparation

Interventions: intervention 1: PEG-ELS intervention 2: BLI800
Intervention descriptions: intervention 1: polyethylene glycol based bowel preparation intervention 2: BLI800 bowel preparation

Protocol document:
Prot_SAP_000.pdf: 
NCT02819323 
STUDY PROTOCOL 
 
A Safety and Efficacy Study of a Bowel Cleansing Preparation (BLI800) 
in Pediatric Subjects Undergoing Colonoscopy 
 
DOCUMENT DATE: 04/18/2016 


 
Version dated 4/18/16 
 
Page 1 of 40 
 
 
A Safety and Efficacy Study of a Bowel Cleansing Preparation 
(BLI800) in Pediatric Subjects Undergoing Colonoscopy 
 
Braintree Protocol BLI800-502 
 
Version Dated 4/18/16 
 
 
 
SPONSOR 
 
 
Braintree Laboratories, Inc. 
60 Columbian St. West 
    
  
 
 
Braintree, MA  02185 
 
 
 
 
PH: 781-843-2202 
 
 
 
 
 
 
 
______________________________________ 
 
_______________ 
Mark v.B. Cleveland, Ph.D.   
 
 
 
Date 
Sr. Vice President, R&D/RA 
Braintree Laboratories, Inc.  
 
 
______________________________________ 
 
_______________ 
Principal Investigator Signature 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Braintree Laboratories, Inc. 
 
Confidential 
Protocol Number BLI800-502 
Version dated 4/18/16 
 
Page 2 of 40 
1. 
INTRODUCTION ........................................................................................................... 4 
2. 
STUDY OBJECTIVE ................................................................................................... 10 
3. 
STUDY PLAN .............................................................................................................. 10 
3.1. 
Study Design ............................................................................................................. 10 
3.2. 
Number of Subjects ................................................................................................... 10 
3.3. 
Duration of Study ...................................................................................................... 10 
3.4. 
Study Preparations ..................................................................................................... 11 
3.5. 
Subject Selection ....................................................................................................... 13 
3.5.1. 
Inclusion Criteria ................................................................................................... 13 
3.5.2. 
Exclusion Criteria .................................................................................................. 14 
3.6. 
Study Endpoints ........................................................................................................ 16 
3.6.1. 
Efficacy ................................................................................................................. 16 
3.6.2. 
Safety ..................................................................................................................... 16 
3.6.3. 
Tolerability ............................................................................................................ 16 
4. 
STUDY PROCEDURES ............................................................................................... 17 
4.1. 
Visit 1 ........................................................................................................................ 17 
4.1.1. 
Randomization ...................................................................................................... 18 
4.1.2. 
Study Drug ............................................................................................................ 19 
4.1.3. 
Preparation Instructions ......................................................................................... 20 
4.2. 
Visit 2 – Day of Colonoscopy ................................................................................... 22 
4.3 
Visit 3 – Day 4 (+/- 1 day) ........................................................................................ 23 
4.4 
Visit 4 – Day 9 (+/- 1 day) ........................................................................................ 23 
4.5 
Visit 5 – Day 32 (+/- 3 day) ...................................................................................... 23 
4.6 
Tabulated Study Procedures ...................................................................................... 24 
4.7 
Subject Preparation Questionnaire ............................................................................ 25 
4.8 
Subject Symptom Scale ............................................................................................. 25 
4.9 
Physician Assessments .............................................................................................. 26 
4.9.1 Segmental Cleansing Assessment ............................................................................. 26 
4.9.2 Overall Cleansing Assessment .................................................................................. 26 
4.9.3 
Additional Efficacy Measures ............................................................................... 26 
4.10 
Pregnancy .................................................................................................................. 27 
4.11 
Concomitant Medications ......................................................................................... 27 
5 
ADVERSE EVENTS .................................................................................................... 28 
5.1 
Adverse Event Definition and Reporting .................................................................. 28 
5.2 
Adverse Events in Prior Clinical Studies .................................................................. 29 
6 
SERIOUS ADVERSE REACTIONS AND DISCONTINUATION OF STUDY ....... 30 
7 
INSTITUTIONAL REVIEW BOARD (IRB) AND INFORMED CONSENT ............ 31 
8 
MANAGEMENT OF INTERCURRENT EVENTS .................................................... 31 
8.1 
Modification of Protocol ........................................................................................... 31 
8.2 
Subjects Discontinued from the Study ...................................................................... 32 
9 
DATA ANALYSIS ....................................................................................................... 33 
10 
DRUG INVENTORY AND DISPOSITION ................................................................ 37 
11 
STUDY MONITORING ............................................................................................... 37 
12 
DOCUMENTS AND NOTIFICATIONS ..................................................................... 37 
13 
PUBLICATION AND AGREEMENT ......................................................................... 39 
14 
INVESTIGATORS AGREEMENT .............................................................................. 39 
15 
REFERENCES .............................................................................................................. 40 
 
 


Braintree Laboratories, Inc. 
 
Confidential 
Protocol Number BLI800-502 
Version dated 4/18/16 
 
Page 3 of 40 
 
CLINICAL PROTOCOL SUMMARY SHEET 
 
STUDY TITLE:   
A Safety and Efficacy Study of a Bowel Cleansing Preparation 
(BLI800) in Pediatric Subjects Undergoing Colonoscopy 
 
PROTOCOL: 
 
BLI800-502 
 
VERSION DATE:  4/18/16 
 
IND NUMBER:  
74,808 
 
STUDY PHASE:   
3 
 
OBJECTIVE:  
To compare the safety, tolerance and efficacy of BLI800 to NuLYTELY 
as bowel preparations prior to colonoscopy in adolescent patients. 
 
STUDY DESIGN:  This will be a randomized, parallel, multi-center, single-blind study. 
 
SUBJECTS:  
Approximately 300 male and female pediatric subjects will be enrolled. 
 
STUDY  
 
 
MEDICATIONS:  
Preparation 1: BLI800 split-dose regimen (6oz per dose) 
 
 
 
 
 
Preparation 2: BLI800 split-dose regimen (4.5oz per dose)  
 
 
 
Preparation 3:  NuLYTELY 
 
 
DURATION:  
Subject participation in this study may last up to 60 days. 
 
 
EFFICACY  
 
ENDPOINTS: 
Primary efficacy will be based on overall preparation success as 
determined by the colonoscopist. Secondary efficacy endpoints will 
include proportion of excellent preparations, preparation quality by 
colon segment and percent of procedures that reach the cecum.  
 
 
 
SAFETY 
 
ENDPOINTS: 
Safety endpoints include:  
• Adverse event reports, including subject reported prep-related 
symptoms 
•  Change in serum chemistry and urine parameters 
•  Change in vital signs  
 
TOLERABILITY 
ENDPOINTS: 
Subject tolerance of the preparation will be graded by caregiver at the 
time of dosing using a scale ranging from “very badly 
accepted/unacceptable” to “very well accepted”.  
















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3.4. Study Preparations 
 BLI800 - SUPREP Bowel Prep Kit 
SUPREP Bowel Prep Kit (Braintree Laboratories, Inc.) is a low-volume osmotic solution that 
is FDA approved for cleansing of the colon as preparation for colonoscopy in adults. SUPREP 
is orally administered in a split-dose regimen and consists of two 6 ounce doses (for dilution), 
each containing the following ingredients in liquid form:  
Component 
Grams 
Na2SO4 
17.51 
MgSO4 
1.6 
K2SO4 
3.13 
Sodium Benzoate 
0.098 
Flavoring agents 
1.35 
Artificial Sweetener 
1.2 
 
Each dose will be supplied in a 6 ounce amber plastic bottle with a Clic-Loc closure. 
Each bottle will have a clinical label containing a caution statement, study code, study 
sponsor and kit number.  
 
BLI800 – 4.5 ounce dose 
A reduced dose (3/4 of the approved SUPREP dose) will be supplied in two 6 ounce 
amber plastic bottles with a Clic-Loc closure. Each bottle will have a clinical label 
containing a caution statement, study code, study sponsor and kit number.  
Component 
Grams 
Na2SO4 
13.13 
MgSO4 
1.2 
K2SO4 
2.35 
Sodium Benzoate 
0.074 
Flavoring agents 
1.01 
Artificial Sweetener 
0.9 
 
 
 


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NuLYTELY 
NuLYTELY (Braintree Laboratories, Inc.) is FDA approved for cleansing of the colon 
as preparation for colonoscopy in pediatric patients. NuLYTELY will be provided in 
clinical packaging with a label containing a caution statement, study code, study 
sponsor, address and kit number.  
 
 
 
 
In this single-blinded study, to ensure an unbiased evaluation of the study preparations, 
the colonoscopist will not be allowed to perform any study drug related activities 
(randomization, drug dispensing, return and accountability). Any failure to maintain 
blinding of the treatment to the colonoscopist will be documented as a protocol violation. 
Subjects and caregivers will be instructed not to discuss their study preparation with any 
staff member. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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3.5. Subject Selection 
3.5.1. Inclusion Criteria 
 
Subjects will be admitted to the study if they are: 
1. Male or female between the ages of 12 to 16 (inclusive) 
 
2. Undergoing colonoscopy for routinely accepted indications, including (but not 
limited to):  
 
▪ Subjected inflammatory bowel disease (IBD) or IBD follow-up 
▪ Lower gastrointestinal bleeding 
▪ Suspected colitis (allergic or other) 
▪ Abdominal pain 
▪ Chronic diarrhea 
▪ Cancer surveillance 
▪ Anemia of unknown etiology 
▪ Abnormal endosonography or manometry 
▪ Evaluation of barium enema results  
 
3. 
If female, and of child-bearing potential, subject must use an acceptable form of 
birth control (hormonal birth control, IUD, double-barrier method, or depot 
contraceptive) or remain abstinent for the duration of the study. 
 
4. Negative pregnancy test at screening, if applicable 
 
5. In the Investigator’s judgment, caregiver is mentally competent to provide 
informed consent for their child to participate in the study. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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3.5.2. Exclusion Criteria  
Subjects who meet any of the following criteria will be excluded from the study: 
 
1. Subjects with known or suspected ileus, impaction, severe ulcerative colitis, acute 
peritonitis, gastrointestinal obstruction, gastric retention (gastroparesis), bowel perforation, 
toxic colitis or megacolon.  
 
2. Subjects who had previous significant gastrointestinal surgeries (e.g. colostomy, 
colectomy, gastric bypass, stomach stapling). Any questions regarding the 
significance of a previous gastrointestinal surgery should be directed to Braintree 
Laboratories. 
 
3. Subjects with increased risk of bowel perforation, including connective tissue 
disorders, toxic dilation of the bowel or recent bowel surgery. 
 
4. Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with 
clinically significant electrolyte abnormalities based on Visit 1 laboratory results, 
such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, 
hypocalcemia, uncorrected dehydration, or those secondary to the use of diuretics 
or angiotensin converting enzyme (ACE) inhibitors. 
 
5. Subjects with bleeding disorders and/or impaired platelet function, or neutropenia. 
 
6. Subjects with a prior history of renal, liver or cardiac insufficiency (including 
congestive heart failure or other significant cardiac abnormality)  
 
7. Subjects with estimated glomerular filtration rate (GFR) below normal range (less 
than 70 ml/min/1.73m2)  
 
8. Subjects required to take any other oral medication within 3 hours of dosing until 
completion of both doses.  
 
9. Subjects with impaired consciousness that predisposes them to pulmonary aspiration. 
 
10. Subjects with tendency for nausea and/or vomiting, or that have known swallowing 
disorders.  
 
11. Subjects for whom intake of substances is likely to affect gastrointestinal motility or 
urinary flow rate. 
 
12. Subjects undergoing colonoscopy for foreign body removal and/or decompression. 
 
13. Subjects with an abnormal ECG result at Visit 1. 
 
14. Subjects who are pregnant or lactating, or intending to become pregnant during the study. 
 
15. Subjects of childbearing potential who refuse a pregnancy test. 


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16. Subjects with a history of hypersensitivity to any preparation components (BLI800: 
sodium sulfate, potassium sulfate, magnesium sulfate and sucralose; NuLYTELY: 
polyethylene glycol 3350, sodium bicarbonate, sodium chloride and potassium 
chloride). 
 
17. Subjects who, in the opinion of the Investigator, should not be included in the study 
for any reason, including inability to follow study procedures and history of major 
medical/psychiatric conditions that would compromise the safety of the study. 
 
18. Subjects who have participated in an investigational surgical, drug, or device study 
within the past 30 days. 
 
19. Subjects who withdraw consent before completion of Visit 1 procedures. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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3.6. Study Endpoints 
3.6.1. Efficacy 
Primary efficacy will be assessed on the basis of preparation success or failure after 
completion of the examination. Investigators will grade each preparation on a scale 
from 1 (poor) to 4 (excellent). This scale is similar to those used in numerous previous 
studies to support the approvals of GoLYTELY, NuLYTELY, HalfLytely with 
Bisacodyl Tablet Bowel Prep Kit and SUPREP Bowel Prep Kit1. Secondary efficacy 
measures are described in Section 4.9.3. 
3.6.2. Safety 
Safety will be assessed through the collection of treatment emergent adverse events, as 
well as changes in vital signs, physical examination findings and serum chemistry 
measures from Visit 1.   
3.6.3. Tolerability 
The tolerability of each dose will be assessed by caregivers using a categorical scale 
inclusive of the following responses: very badly accepted/unacceptable; badly, but 
accepted; neither good nor bad; well accepted; very well accepted.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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4. STUDY PROCEDURES 
Study procedures are described as follows and depicted graphically in Section 4.6, 
below. 
4.1. Visit 1 
Following the informed consent process, caregivers will sign a consent form. Subjects 
of age to provide assent (as determined by the IRB for each center) will sign an assent 
form. Subject’s demographics and concomitant medications will be recorded, vital 
signs will be obtained (including temperature, heart rate, respiratory rate, orthostatic 
manual blood pressure, height and weight), and a physical examination will be 
performed.  An electrocardiogram (ECG) will be performed and subjects with an 
abnormal ECG will be excluded from continuing in the study. Medical history will be 
recorded to include all ongoing conditions at Visit 1 as well as any significant 
conditions, defined as:  
Abdominal surgeries, Renal failure/dysfunction, Liver failure/dysfunction, 
Cardiac disorders (e.g. myocardial infarction, coronary artery disease 
tachycardia), Hypertension, Inflammatory Bowel Disease, Rectal Bleeding, 
Polyposis, Diabetes, Cancer (must indicate type of cancer), Electrolyte 
abnormalities 
Blood and urine samples will be collected for testing at a central laboratory. The 
specific testing to be conducted is described below. Please refer to the laboratory 
manual for detailed instructions on sample processing. Colonoscopies must be 
scheduled to allow for receipt of laboratory results prior to the day the subject is 
scheduled to begin preparation.  
 
Serum Testing: albumin, ALT, anion gap, AST, bicarbonate, total bilirubin, 
blood urea nitrogen, calcium, chloride, creatine kinase (CK), creatinine, eGFR, 
GGT, glucose, HCG, magnesium, osmolality, osmolar gap, phosphorus, 
potassium, sodium, sulfate, total protein, and uric acid. CK-MB will be tested in 
samples where the CK value is greater than 2.5 times the upper normal limit. 
 


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Urine Testing: standard spot urinalysis (including microscopic analysis and 
ketones)  
 
Investigators will be notified promptly by the central laboratory if a critical 
result is reported for the following tests:  
 
Calcium 
 
< 6.1 mg/dL (low) 
> 12.9 mg/dL (high) 
 
Creatine Kinase 
> 2000 U/L 
 
Glucose 
 
< 40 mg/dL (low) 
> 450 mg/dL (high) 
 
Potassium 
 
< 2.8 mEq/L (low) 
> 6.3 mEq/L (high) 
 
 
 
Sodium 
 
< 117 mEq/L (low) 
> 160 mEq/L (high) 
 
 
 
HCG  
 
Positive 
 
Investigators should discontinue subjects with a critical value unless they feel 
the result is erroneous due to poor sample quality or laboratory error. In such 
cases the investigator must perform a redraw.  
 
Subjects meeting all entry criteria will be eligible for randomization. 
 
 
4.1.1. Randomization  
Subjects that meet eligibility criteria will be randomized using an automated interactive 
web response system (IWRS). The randomization schedule will be implemented in the 
automated interactive web response (IWR) system prior to kit distribution to the site. 
At the time of randomization the IWRS will assign a drug kit number for site personnel 
to dispense to the subject. Subjects will be stratified into one of the following two 
groups:  
Group 1: Subjects with a baseline weight > 40 kg 
Group 2: Subjects with a baseline weight < 40 kg 
 
The site personnel must only dispense a drug kit that has been assigned by the IWRS.  
Dispensing kits out of order is considered a protocol violation.  


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Subjects and caregivers will be provided with instructions on how to administer the 
study preparation. Subjects will be provided with a Preparation Questionnaire (see 
Section 4.7) to report their experience with the study preparation. Subjects will 
complete this questionnaire from the time the first dose of study drug is taken until the 
colonoscopy and will return it to the clinic at Visit 2.  Subjects should complete the 
questionnaire themselves; however, in the event that subjects are unable to complete 
the questionnaire, caregivers are allowed to do so. Subject intake of food, beverages 
(including amounts) and medications will be recorded in a specific section of this 
questionnaire. 
 
4.1.2. Study Drug 
The study preparation will be administered starting on the day prior to the scheduled 
colonoscopy according to the instructions noted in Section 4.1.3. Caregivers/subjects 
will be instructed to bring the used preparation components when they return for 
colonoscopy.  
 
Subjects that have clinically significant electrolyte abnormalities, in the opinion of the 
principle investigator, based on Visit 1 laboratory results must be discontinued from 
the study. Caregivers/subjects must be notified and instructed to return the unopened 
bowel preparation to the study center.  Returned un-used study drug kits will not be re-
dispensed to another subject.    
 
 
 
 
 
 
 
 


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4.1.3. Preparation Instructions 
BLI800 (6 oz dose)  
DAY 1 (evening before colonoscopy) 
 
1. Take a 6 ounce bottle of study preparation and pour the entire contents into the  
mixing cup provided.  Fill the cup with cool water to the fill line (16 ounces) 
and drink the entire cup of solution.  
 
2. Drink two (2) 16 ounce glasses of WATER over the next 1 – 2 hours.  Fill the  
mixing cup with water up to the fill line (16 ounces) and drink the entire glass. 
 
 
 
DAY 2 (morning of colonoscopy) 
 
3. At least 3 hours prior to your procedure:  
Take the second 6 ounce bottle of study preparation and pour the entire contents 
into the mixing cup provided.  Fill the cup with cool water to the fill line (16 
ounces) and drink the entire cup of solution.  
 
4. Drink two (2) 16 ounce glasses of WATER over the next 1 – 2 hours. Fill the  
mixing cup with water up to the fill line (16 ounces) and drink the entire glass. 
You must complete the solution and additional water at least 2 hours before 
your colonoscopy.  
 
 
BLI800 (4.5 oz dose)  
DAY 1 (evening before colonoscopy) 
 
1. Take a 6 ounce bottle of study preparation and pour the entire contents into the  
mixing cup provided.  Fill the cup with cool water to the fill line (12 ounces) 
and drink the entire cup of solution.  
 
2. Drink two (2) 12 ounce glasses of WATER over the next 1 – 2 hours.  Fill the  
mixing cup with water up to the fill line (12 ounces) and drink the entire glass. 
 
 
DAY 2 (morning of colonoscopy) 
 
3. At least 3 hours prior to your procedure:  
Take the second 6 ounce bottle of study preparation and pour the entire contents 
into the mixing cup provided.  Fill the cup with cool water to the fill line (12 
ounces) and drink the entire cup of solution.  
 
4. Drink two (2) 12 ounce glasses of WATER over the next 1 – 2 hours. Fill the  
mixing cup with water up to the fill line (12 ounces) and drink the entire glass. 
You must complete the solution and additional water at least 2 hours before 
your colonoscopy.  
 
Early morning colonoscopies should be scheduled accordingly to allow for completion of 
the Day 2 preparation dosing within the specified timeframes. 


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NuLYTELY  
 
DAY 1 (evening before colonoscopy) 
 
1. Tear open 1 (one) flavor pack of choice and pour into NuLYTELY bottle.  Add 
lukewarm drinking water to the fill mark (4 liters) on the NuLYTELY bottle.  
Do not add any other ingredients, flavors, etc. 
 
2. Cap bottle securely and shake vigorously several times to dissolve powder. The 
bottle may be refrigerated to improve palatability. Note: once the solution is 
reconstituted it must be used within 48 hours. 
 
3. Begin drinking solution at a rate of 25 ml/kg/hour until your bowel movements 
run clear and free of solid matter or until you have completed the entire 4 liters 
of solution. 
 
 
 
Dietary Restrictions 
BLI800 subjects may have a light breakfast on the day before colonoscopy, followed 
by clear liquids until the colonoscopy is completed the following day.  
 
NuLYTELY subjects may only have clear liquids on the day prior to colonoscopy until 
completion of the colonoscopy the following day.  
 
Examples of acceptable clear liquids for both preparations are noted below: 
▪ Water 
▪ Strained fruit juices (without pulp) including apple, orange, white grape, or   
            white cranberry  
▪ Limeade or lemonade 
▪ Gatorade/ Powerade 
▪ Ginger ale 
▪ Coffee or tea (do not use any dairy or non-dairy creamer) 
▪ Chicken broth 
▪ Gelatin desserts without added fruit or topping 
Note: Purple/Red liquids, Milk and Alcoholic beverages are not permitted. 
 
Non-compliance with the dietary restrictions will be documented, but will not require 
separate reporting as a protocol violation. 
 


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4.2. Visit 2 – Day of Colonoscopy 
Subjects and Caregivers will return to the study center for colonoscopy following 
completion of the preparation. Sites should attempt to schedule subjects a minimum of 4 
days from date of screening to allow for receipt and review of screening lab results up to a 
maximum of 30 days. Visits scheduled beyond 30 days from Visit 1 will be considered a 
protocol violation and subjects must have a repeat blood draw.  
 
Subjects/Caregivers will bring back the Preparation Questionnaire. Study personnel 
must review the questionnaire for completeness in the presence of the subject/caregiver 
so that any missed responses can be captured. Any violations of the dietary restrictions 
must be confirmed with the subject. 
 
Subject’s vital signs (see section 4.1 for details) will be repeated, a physical 
examination will be performed, and the subject will be queried for occurrence of 
adverse events and changes in concomitant medications. Blood and urine samples will 
be collected for laboratory testing.  
 
Prior to the colonoscopy, subjects will complete the Symptom Scale (see Section 4.8) 
to report their overall experience with the preparation.  
 
The colonoscopy will be performed by a physician according to the site’s standard 
procedures and evaluated on a 4-point scale, as shown in Section 4.9. Additional data 
will be collected as outlined in Section 4.9.3. 
 
Subjects will be instructed to bring the used preparation components when they return for 
colonoscopy to determine compliance. Failure of a subject to return preparation 
components does not constitute a protocol violation. Staff members will perform drug 
accountability by assessing the number of used BLI800 bottles and volume of remaining 
solution in the NuLYTELY jug. 
 
All used and unused components of study preparation must be accounted for on the drug 
inventory log and will be returned to the Sponsor at the completion or termination of the 
study, unless instructed otherwise by the Sponsor. 


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4.3 Visit 3 – Day 4 (+/- 1 day) 
 
Subjects will return to the study center 2 days (+/- 1 day) after colonoscopy. Subject’s 
vital signs (see section 4.1 for details) will be repeated and the subject will be queried 
for occurrence of adverse events and changes in concomitant medications. Blood and 
urine samples will be collected for laboratory testing. 
4.4 Visit 4 – Day 9 (+/- 1 day) 
 
Subjects will return to the study center 7 days (+/- 1 day) after colonoscopy. Subject’s 
vital signs (see section 4.1 for details) will be repeated and the subject will be queried 
for occurrence of adverse events and changes in concomitant medications. Blood and 
urine samples will be collected for laboratory testing. 
4.5  Visit 5 – Day 32 (+/- 3 day)    
Subjects with persistently abnormal laboratory results and ongoing adverse events at 
Visit 4 will return to the study center 30 days (+/- 1 day) after colonoscopy. Additional 
blood and/or urine samples will be collected and symptoms assessed as indicated. For 
subjects with ongoing abnormalities at Visit 5, site personnel should consult with the 
Sponsor and Medical Monitor to determine if additional follow up is required. 


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4.6 Tabulated Study Procedures 
The following graphically depicts the flow of study procedures at each visit. 
Procedures 
Visit 1 
Screening 
Between 4 and 30 
days prior to 
colonoscopy 
 
Day 1 
Day Before 
Colonoscopy 
Visit 2 
Day 2 
Colonoscopy 
Visit 3 
Day 4 
(+/- 1 days) 
Visit 4 
Day 9 
(+/- 1 days) 
Visit 54 
Day 32 
(+/- 1 days) 
Informed Consent/Assent 
X 
 
 
 
 
 
Inclusion/Exclusion Criteria Review 
X 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
Physical Examination 
X 
 
X 
X 
X 
 
Vital Signs1 
X 
 
X 
X 
X 
 
Review of Concomitant Medication 
X 
 
X 
X 
X 
X 
Blood Collection for Serum Chemistry Testing 
X 
 
X 
X 
X 
X 
Urine Collection for Urinalysis 
X 
 
X 
X 
X 
X 
Electrocardiogram 
X 
 
 
 
 
 
Serum Pregnancy Test (if applicable)2 
X 
 
 
 
 
 
Randomization 
X 
 
 
 
 
 
Dispense Drug & Questionnaires 
X 
 
 
 
 
 
Instruct Subject 
X 
 
 
 
 
 
Subject Takes 1st  Dose of Preparation 
 
X 
 
 
 
 
Subject Completes Preparation Questionnaire  
 
X 
X 
 
 
 
Subject Takes 2nd  Dose of Preparation (BLI800 only) 
 
 
X 
 
 
 
Subject Completes Symptom Scale3 
 
 
X 
 
 
 
Drug Accountability 
 
 
X 
 
 
 
Colonoscopy performed with Intra-procedural Safety 
and Efficacy Grading 
 
 
X 
 
 
 
Collect and assess adverse event data 
 
X 
X 
X 
X 
X 
1 Includes assessments of height (Visit 1 only), oral temperature, heart rate, respiratory rate, manual blood pressure and weight 
2 refer to Section 4.10 
 
3to be dispensed and completed at Visit 2, prior to colonoscopy  
4Visit 5 will be performed only for subjects with ongoing adverse events or that have clinically significant lab values at Visit 4 


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4.7 Subject Preparation Questionnaire  
A Preparation Questionnaire will be completed by the subject from the time the 
preparation is started until the subject completes the preparation. This questionnaire 
must be returned to a member of site staff at Visit 2. The questionnaire will prompt 
subjects for dosing and completion times for the study preparation and additional water 
(including water amount), and will contain questions about their bowel movement 
experiences during the preparation.  
 
The section of the questionnaire entitled Dietary Compliance should be completed 
from the morning the subject starts their study preparation (i.e. day before the 
colonoscopy) until their procedure the following day. The subject will be instructed 
to record all food and beverages consumed during this two day period, keeping in 
mind the dietary restrictions outlined above in Section 4.1.3.  
 
The section of the questionnaire entitled Dosing Tolerability should be completed by 
the caregiver after the subject completes each dose of preparation (NuLYTELY 
subjects will only have one questionnaire). Caregivers will be asked to rate subject 
tolerability using the following categories:  
- Very badly accepted/ unacceptable: subject showed great displeasure, 
compromising use of formulation 
- Badly but accepted: subject showed displeasure with dosing but could be 
coaxed to take complete dose 
- Neither good nor bad: subject showed no apparent displeasure and with little 
effort was coaxed to take complete dose 
- Well accepted: subject appeared to enjoy the formulation and with little 
coaxing ingested most of dose 
- Very well accepted: subject appeared eager and ingested most of dose 
without special coaxing. 
 
4.8 Subject Symptom Scale 
 
This questionnaire will be completed by the subject at Visit 2, prior to colonoscopy. 
Subjects will rate their overall experience of stomach cramping, stomach bloating and 


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nausea on a 5 point scale, with 1 = no symptoms and 5 = severely distressing 
symptoms.  
 
4.9 Physician Assessments 
4.9.1 Segmental Cleansing Assessment 
The blinded colonoscopist will rate each colon segment (proximal, mid, distal) using 
the following scale. This assessment will be performed during the withdrawal portion 
of the examination.  
 
Score 
Grade 
Description 
1 
Poor 
Large amounts of fecal residue, additional 
bowel preparation required 
2 
Fair 
Enough feces even after washing and suctioning 
to prevent clear visualization of the entire 
colonic mucosa. 
3 
Good 
Feces and fluid requiring washing and 
suctioning, but still achieves clear visualization 
of the entire colonic mucosa. 
4 
Excellent 
No more than small bits of feces/fluid which 
can be suctioned easily; achieves clear 
visualization of the entire colonic mucosa 
 
 
4.9.2 Overall Cleansing Assessment 
The blinded colonoscopist will provide a global rating of preparation quality for the 
entire colon (inclusive of their perception of all segments) using the scale outlined in 
Section 4.9.1.  This assessment will be performed upon completion of the 
examination (withdrawal of the endoscope).   
 
4.9.3 Additional Efficacy Measures 
In addition, the following data will be collected: 


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1. Adequacy of preparation according to the blinded colonoscopist. If the 
preparation was not adequate, the need for re-preparation will be 
recorded.  
2. Start time of colonoscopy 
3. Time of cecal intubation 
4. Completion time of colonoscopy 
5. Volume of water used to improve visualization 
 
4.10 Pregnancy 
All female subjects must have a serum pregnancy test done at screening. A positive 
result will rule out the participation of the subject in the study. 
 
Female study subjects must use oral contraceptives, depot contraceptives, double-
barrier method, intrauterine device, or testify that she is monogamous, or practices 
abstinence and will continue to do so during the duration of study. Subjects 
practicing abstinence must agree to use an acceptable form of birth control should 
they become sexually active during the study.  
 
Oral contraceptives, hormone implants, and injections should be stable for at least 1 
month before colonoscopy, until 1 month after colonoscopy.  
 
If a subject becomes pregnant during the study, the subject must be removed from 
the study and followed until one month after the end of the pregnancy.  A pregnancy 
will not be recorded as an adverse event.  
4.11 Concomitant Medications 
The use of concomitant medication (defined as prescription, over the counter and 
homeopathic medications) will be recorded from 14 days prior to screening until 
completion of Visit 5 (Day 32), including sedation medications and intravenous fluids 
administered during colonoscopy.  


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5 
ADVERSE EVENTS  
5.1 Adverse Event Definition and Reporting 
An Adverse Event (AE) is any untoward medical occurrence associated with the use of a 
drug in humans, whether or not considered drug related. An AE can therefore be any 
unfavorable and unintended sign (including a clinically significant abnormal laboratory 
finding), symptom, or disease temporally associated with the use of a medicinal 
(investigational) product.  Subjects will be queried for any problems they experienced 
during and after preparation by site personnel. Site personnel should review the 
preparation questionnaire section related to adverse events and discuss any documented 
events with subjects/caregivers.  
 
In addition, any symptom on the symptom scale rated as 2 (mild) to 5 (severely 
distressing) must be reported as an adverse event. Reports of vomiting (of any severity) 
must be documented as adverse events. If multiple episodes of vomiting are reported on 
the Treatment Questionnaire, these should be represented as one adverse event on the 
case report form with severity reflecting the most severe episode. 
 
Any abnormal anion gap laboratory finding must be reported as an adverse event and 
followed until resolution. Colonoscopy and biopsy findings are not considered adverse 
events unless considered by the investigator to be related to the preparation or 
colonoscopy procedure.  
Adverse event collection will commence at the time the patient provides informed 
consent to participate in the study and will conclude with the completion of Visit 4. For 
subjects requiring Visit 5, adverse events will be collected until completion of Visit 5.  
 
Subjects will be instructed to promptly report adverse events to the Investigator. The 
Investigator will record date/time of report, date/time of onset, description of the adverse 
event, severity of adverse event, action(s) taken regarding treatment of the event, 
action(s) taken regarding study participation, duration of adverse event, and the 
Investigator's assessment of relationship of adverse event to study preparation.  


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The Investigator should assess the severity of each adverse event using the following 
categories: 
Grade 
Severity 
Description 
1 
Mild 
Barely noticeable, does not influence functioning 
causing no limitations of usual activities 
2 
Moderate 
Makes participant uncomfortable, influences functioning 
causing some limitations of usual activities 
3 
Severe 
Severe discomfort, treatment needed 
Severe and undesirable, causing inability to carry out usual 
activities 
4 
Life 
threatening 
Immediate risk of death, Life threatening or disabling 
(Must be reported as serious adverse event) 
5 
Fatal 
Causes death of the participant 
(Must be reported as serious adverse event)  
 
The Investigator should assess the relationship to study drug for each adverse event 
using the following categories: 
Categories of 
Attribution:  
Description 
UNRELATED 
There is no evidence of any causal relationship. 
POSSIBLE 
There is some evidence to suggest a causal relationship (e.g., the 
event occurred within a reasonable time after administration of 
the trial medication). However, the influence of other factors 
may have contributed to the event (e.g., the subject’s clinical 
condition, other concomitant events). 
PROBABLE 
There is evidence to suggest a causal relationship, and the 
influence of other factors is unlikely. 
DEFINITE 
There is clear evidence to suggest a causal relationship, and 
other possible contributing factors can be ruled out. 
 
5.2 
Adverse Events in Prior Clinical Studies 
BLI800 
In Phase 3 clinical trials of adult subjects, the most frequent adverse events reported 
by patients taking SUPREP (reported by >3% of patients) included overall 
discomfort, abdominal pain and distension, nausea, and vomiting. In a pilot study in 
adolescents (Study BLI800-501), the incidences of nausea, vomiting, abdominal pain 
and bloating were similar to those seen in adults. Most subjects reported no 
symptoms or rated them as mild.  


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6 
SERIOUS ADVERSE REACTIONS AND DISCONTINUATION OF STUDY 
A Serious Adverse Event (SAE) is any untoward medical occurrence that results in 
at least one of the following outcomes: 
 
- 
Results in death 
- 
Is life-threatening 
- 
Requires inpatient hospitalization or prolongation of existing hospitalization 
- 
A persistent or significant incapacity or substantial disruption of the ability to 
conduct normal life functions 
- 
Is a congenital anomaly/birth defect 
- 
Requires medical or surgical intervention to prevent permanent impairment 
or damage 
 
 
SAE collection will coincide with the patient providing informed consent to 
participate in the study and will conclude 30 days after the subject took their 
preparation. Pre-scheduled surgeries, or examination findings not related to the 
preparation will not be considered serious adverse events. Should a serious and/or 
unexpected adverse event occur, the Investigator will notify Braintree Laboratories 
immediately or no later than 24 hours after gaining knowledge of the event.  The 
Investigator will make a decision regarding continuing study participation, and may 
request input from Braintree Laboratories. The Investigator will be responsible for 
recommending or providing the patient with appropriate medical therapy. All patients 
experiencing serious adverse events will be followed until clinically stable.  
 
Braintree Laboratories must be kept apprised of all follow-up information 
related to serious adverse events. In addition, Investigators must comply with the SAE 
reporting requirements of the Institutional Review Board with oversight of the study. 
 
 
 
 
 




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8.2 Subjects Discontinued from the Study 
Subjects may be dropped from the study for any of the following reasons: 
• Subject/caregiver chooses to withdraw from the study, for whatever reason. 
• An adverse event requiring discontinuation (including failure to tolerate study 
medication). 
• Major protocol deviation from the study design by the subject that is observed or 
suspected by the Investigator 
• Subject is lost to follow-up. 
• Female participants who become pregnant during the study period. 
• The subject is withdrawn at the discretion of the Investigator. 
• The Sponsor initiates an early discontinuation of the study. 
 
Braintree should be contacted if possible prior to discontinuation of any subject. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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9 
DATA ANALYSIS 
9.1 Efficacy 
Primary efficacy will be assessed on the basis of a binary outcome of overall 
preparation success or failure. For statistical analyses, the following definition of 
preparation success and failure will be used: 
 
Definition of successful preparation:  
1. Overall Cleansing Assessment by the colonoscopist (Section 4.9.2) of 
“Excellent” or “Good” and does not satisfy any of the following failure criteria.    
 
 
Definition of failed preparation:  
1. Overall Cleansing Assessment of “Fair” or “Poor” by the colonoscopist 
2. Any subject who did not have a colonoscopy based on the Investigator’s 
assessment of the cleansing (insufficient fecal output, unclear fecal discharge, 
etc.) or due to preparation related adverse events. 
 
3. Any subject for whom cleaning was not adequate for evaluation 
 
Inevaluable Patients: 
Subjects who were dispensed a kit but withdrew from the study prior to taking any 
preparation (including subjects who were disqualified subsequent to Visit 1 based on 
screening laboratory results) are excluded from the efficacy and safety analyses. Any 
subject who completely or partially took study preparation but did not have a 
colonoscopy due to non-preparation related reasons will not be included in the 
efficacy analyses. All treated subjects will be included in the safety analysis. 
 
Superiority Hypothesis: 
The primary endpoint of treatment success will be based upon the difference D=P1-
P2, where P1 is the observed success fraction in the BLI800 group (experimental 
group) and P2 is the observed success fraction in the NuLYTELY group (control 
group).  The procedure tests the null hypothesis 
H0: π1-π2=0 
versus the alternative hypothesis 
H1: π1-π2 ≠0, 


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where π1 is the true underlying probability of successful treatment in the BLI800 
group, and π2 is the true underlying success probability in the NuLYTELY group.   
 
We will test the null hypothesis of superiority separately for the comparisons of full-
dose BLI800 vs. NuLYTELY and 4.5-ounce BLI800 vs. NuLYTELY.  We will 
preserve the family-wise type I error rate at 5% using the Holm-Bonferroni 
approach, which involves comparing the smaller of the two P values to 0.025 and, if 
that is significant, the larger of the two P values to 0.05.  If both comparisons are 
significant, we will conduct a test comparing the two dose levels of BLI800 at the 
two-sided 5% level.  As we will only perform this test conditionally on the other 
tests being significant, it has no effect on the family-wise type I error rate, and so it 
requires no further multiplicity adjustment. 
 
Secondary endpoints will be analyzed in a manner similar to the primary analysis 
using the CMH test adjusting for site effects for count (percentage) outcomes and 
two-way ANOVA with terms for treatment, site, and their interaction for continuous 
responses. No adjustment will be made for multiplicity in testing the secondary 
endpoints.  P values will be presented for hypothesis tests, and two-sided 95% 
confidence intervals for estimates of treatment effects. 
 
 
Secondary efficacy endpoints will include proportion of excellent preparations, 
cleansing score by segment, proportion of examinations that reach the cecum, and 
volume of additional water used for washing.  
 
9.2 Safety 
Adverse Events: 
All subjects who took preparation in any amount will be included in the safety 
analysis. All adverse events will be analyzed based on the principle of treatment 
emergence. A sign or symptom will be regarded as treatment-emergent if it was 
present prior to the first dose and subsequently worsened in severity, or was not 
present prior to the first dose but subsequently appeared. 
 


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In order to define treatment emergence for events with missing start or stop dates the 
following additional criteria will be used: 
• 
if both the onset and resolution dates for a particular event are missing, then 
the event is considered treatment-emergent; 
• 
if the onset date for an event is missing and the resolution date falls after the 
initiation of the first dose, then the event is considered treatment-emergent; 
• 
if the onset date for an event falls after the initiation of the first dose and the 
resolution date is missing or present, then the event is considered treatment-
emergent; and 
• 
if the onset date for an event falls before the initiation of the first dose and the 
stop date is missing or present, then the event is not considered treatment-
emergent. 
 
Adverse events will be collected using MedDRA category designations for body 
system and preferred term. The number and percent of subjects who experienced 
each adverse event will be presented in a tabular form.  Individual tables will be 
provided for treatment-emergent adverse events, treatment-emergent adverse events 
by relationship to study drug, and treatment-emergent adverse events by severity. 
The difference in adverse events between study populations will be tested by the 
Fisher’s exact test together with a 95% confidence interval for the treatment effect 
estimate. 
 
Vitals Signs and Physical Examination: 
Vital signs and physical examination data will be summarized with descriptive 
statistics. 
 
Laboratory Data: 
Results of laboratory tests for the change from baseline (Screening) and treatment 
group differences will be tested using ANOVA.  In addition, shift tables will be 
presented to describe changes in lab parameter values between screening and post-
treatment time points using normal range categories (low, normal, high).  
 


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Symptom Questionnaire Data: 
Symptom questionnaire data for individual symptoms for Overall Experience 
(Stomach Cramping, Stomach Bloating and Nausea) will be presented categorically 
by severity and tested by Chi-Square test. 
 
9.3 Tolerability 
Tolerability data will be presented categorically and tested by Chi-Square test.  
 
9.4 Sample Size 
The primary aim of the study is to show that BLI800 is superior to NuLYTELY in 
the proportion of subjects with successful colon cleansing. Based on prior studies in 
adult subjects, the proportion of subjects experiencing successful cleansing is 
expected to be approximately 95% in the BLI800 group and 77% in the NuLYTELY 
group. We will test the hypothesis of superiority separately for the two BLI800 dose 
groups:  BLI800 full dose vs. NuLYTELY, and BLI800 4.5 ounce dose vs. 
NuLYTELY.  To control the family-wise type I error rate at 5%, we will perform a 
Holm-Bonferroni adjustment, testing the hypothesis for the smaller of the two P 
values at the two-sided 2.5% level and, if significant, testing the hypothesis for the 
larger of the two P values at the two-sided 5% level.  Assuming similar rates in the 
adolescent population and a one-sided alpha of 0.0125, with 81 subjects per group 
(243 total), the study will have 80% power to reject the null hypothesis of 
equivalence. 100 subjects will be enrolled in each preparation group to account for 
dropouts.  
 
9.5. 
Study Populations 
The following populations have been defined for data analyses. 
9.5.1.Intention-to-Treat (ITT) Population 
This population includes all subjects randomized to treatment. Safety and efficacy 
analyses using the ITT population will be used to support the primary study analyses 
using the modified ITT population.  


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9.5.2. 
Modified Intention-to-Treat (mITT) Population  
This population consists of all randomized subjects that took at least one dose of 
study medication. The mITT population will serve as the analysis population for all 
primary and secondary safety and efficacy analyses. Safety and efficacy analyses 
using the mITT population will be used to support the primary study analyses using 
the per-protocol population. 
9.5.3. 
Per Protocol Population  
The per-protocol (PP) population will consist of all subjects in the mITT population 
who have not violated any major entry criteria and have not deviated significantly 
from the protocol during the course of the study. Reasons for exclusion from the PP 
population will be defined prospectively in the statistical analysis plan and prior to 
unblinding of the data. Safety and efficacy analyses using the per-population will be 
used to support the primary study analyses using the per-protocol population. 
 
10 
DRUG INVENTORY AND DISPOSITION 
At the conclusion of the study, all drug materials will be accounted for.  Federal law 
requires that, at the conclusion of the study, all drug materials must be returned to the 
study sponsor or destroyed according to local regulations.  
11 
STUDY MONITORING 
 
A Braintree Laboratories Study Monitor or qualified designee will visit each study 
center prior to the commencement of the study and periodically during the course of 
the study in accordance with federal guidelines governing the sponsorship of studies. 
12 
DOCUMENTS AND NOTIFICATIONS 
12.1 Informed Consent 
Written informed consent will be obtained from a parent/guardian by study personnel 
and will be kept on file at the study center (and assent for children of appropriate 


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age). Documentation of the consent process should be noted in the study source 
documents. 
12.2 Institutional Review Board 
Peer review and approval of the protocol by an appropriate Institutional Review 
Board is required prior to commencement of enrollment.  Amendments to the 
approved protocol must also be submitted to the Institutional Review Board and 
approved prior to their implementation.  
 
12.3 Amendments to the Protocol 
If Braintree Laboratories determines that there is need for an amendment, it will be 
produced in writing by Braintree Laboratories and will be made a formal part of the 
protocol following its submission and approval from the IRB.    
12.4 Data Records 
Braintree Laboratories will provide appropriate electronic case report forms for each 
subject. Subject medical records will be reviewed to verify all other data points, 
including potential adverse events, and to ensure consistency with the report forms.  
Copies will be made and retained by the Investigator as well as identical copies for 
Braintree Laboratories’ files. Copies of subjects’ laboratory reports, colonoscopy and 
pathology reports (if applicable) will be collected for Braintree Laboratories after 
subject identifiers have been redacted by site staff. The Investigator should retain 
copies of the report forms, subject consent forms, and other study documents for a 
period of two years following the date of approval of a New Drug Application or 
supplement for BLI800, or, if the application is not approved, for two years after the 
drug investigation program is discontinued. The study investigator will notify 
Braintree Laboratories of their intent to dispose of the study records and allow 
Braintree to take possession of such records. Study records will be made available at 
reasonable times for inspection and copying if requested by a properly authorized 
employee of Braintree Laboratories, authorized Braintree Laboratories designee or 
the Department of Health and Human Services in accordance with federal 
regulations.  




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15 
REFERENCES 
1 - Di Palma JA, Rodriguez R, McGowan J, Cleveland MvB. A randomized clinical 
study evaluating the safety and efficacy of a new, reduced-volume, oral sulfate 
colon-cleansing preparation for colonoscopy. Am J Gastroenterol. 2009;104:2275-
2284. 
2 - Rex DK, Di Palma JA, Rodriguez R, McGowan J, Cleveland M. A randomized 
clinical study comparing reduced-volume oral sulfate solution with standard 4-liter 
sulfate-free electrolyte lavage solution as preparation for colonoscopy. Gastrointest 
Endosc. 2010;72:328-336. 
3 – Bitoun A, Ponchon T, Barthet M, Coffins B, Dugue C, Halphen M:  Results of a 
prospective randomized multicenter controlled trial comparing a new 2-L ascorbic 
acid plus polyethylene glycol and electrolyte solution vs. sodium phosphate solution 
in patients undergoing elective colonoscopy.  Aliment Pharmacol Ther.;24:1631-
1642, 2006.