Clinical trial NCT03023085
Conditions: Colonoscopy
Sponsor: Braintree Laboratories
Start date: 2016-08-01; Completion date: 2017-08-01
Enrollment: 120 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to evaluate the safety and efficacy of BLI4700 as a bowel preparation prior to colonoscopy in adult patients.

Detailed description:

Arms: arm 1: BLI4700 Bowel Preparation
Interventions: intervention 1: BLI4700
Intervention descriptions: intervention 1: BLI4700 bowel preparation

Protocol documents:
Prot_SAP_000.pdf: 
NCT03023085 
STUDY PROTOCOL 
 
A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects 
 
DOCUMENT DATE: 06/15/2017 


 
Version dated 15 JUN 2017 
 
Page 1 of 33 
 
 
A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects 
 
Braintree Protocol BLI4700-201 
 
Version Dated 15 June 2017  
 
 
 
SPONSOR 
 
 
Braintree Laboratories, Inc. 
60 Columbian St. West 
    
  
 
 
Braintree, MA  02185 
 
 
 
 
PH: 781-843-2202 
 
MEDICAL   
 
Jack DiPalma, MD 
MONITOR  
 
University of South Alabama  
Division of Gastroenterology 
75 University Blvd, South 
UCOM 6000 
Mobile, AL 36688 
PH: 251-660-5553 
 
 
 
 
 
 
 
 
______________________________________ 
 
_______________ 
Mark v.B. Cleveland, Ph.D.   
 
 
 
Date 
Sr. Vice President, R&D/RA 
Braintree Laboratories, Inc.  
 
 
______________________________________ 
 
_______________ 
Principal Investigator Signature 
 
 
 
Date 
 
 
______________________________________ 
 
 
Principal Investigator Name (printed) 
 
 
 
 
 
 
 
 
 
 


Braintree Laboratories, Inc. 
 
Confidential 
Protocol Number BLI4700-201 
Version dated 15 JUN 2017 
 
Page 2 of 33 
 
1. 
INTRODUCTION .......................................................................................................... 4 
2. 
STUDY OBJECTIVE .................................................................................................. 11 
3. 
STUDY PLAN .............................................................................................................. 11 
3.1. 
STUDY DESIGN ........................................................................................................ 11 
3.2. 
NUMBER OF SUBJECTS............................................................................................. 11 
3.3. 
DURATION OF STUDY .............................................................................................. 11 
3.4. 
STUDY PREPARATIONS ............................................................................................ 12 
3.5. 
SUBJECT SELECTION ................................................................................................ 13 
3.5.1. 
Inclusion Criteria .......................................................................................... 13 
3.5.2. 
Exclusion Criteria ......................................................................................... 13 
4. 
STUDY PROCEDURES .............................................................................................. 14 
4.1. 
VISIT 1 .................................................................................................................... 14 
4.1.1. 
Study Drug ..................................................................................................... 15 
4.1.2. 
Dietary Restrictions ....................................................................................... 16 
4.1.3. 
Subject Questionnaires .................................................................................. 16 
4.2. 
BOWEL PREPARATION ADMINISTRATION ................................................................ 16 
4.3. 
VISIT 2 .................................................................................................................... 17 
4.3.1. 
Symptom Scale ............................................................................................... 17 
4.3.2. 
Drug Accountability ...................................................................................... 18 
4.4. 
FOLLOW UP OF ADVERSE EVENTS AND LABORATORY RESULTS ............................. 18 
4.5. 
TABULATED STUDY PROCEDURES ........................................................................... 19 
4.6 
PHYSICIAN ASSESSMENTS ....................................................................................... 20 
4.6.1. 
Segmental Cleansing Assessment ................................................................. 20 
4.6.2. 
Overall Cleansing Assessment ...................................................................... 20 
4.6.3. 
Additional Efficacy Measures ....................................................................... 20 
4.7. 
PREGNANCY ............................................................................................................ 21 
4.8. 
CONCOMITANT MEDICATIONS ................................................................................. 22 
5. 
ADVERSE EVENTS .................................................................................................... 22 
5.1. 
ADVERSE EVENT DEFINITION AND REPORTING ....................................................... 22 
5.2 
EXPECTED ADVERSE EVENTS .................................................................................. 24 
6. 
SERIOUS ADVERSE REACTIONS AND DISCONTINUATION OF STUDY ... 24 
7. 
INSTITUTIONAL REVIEW BOARD (IRB) AND INFORMED CONSENT ....... 25 
8. 
MANAGEMENT OF INTERCURRENT EVENTS ................................................. 25 
8.1. 
MODIFICATION OF PROTOCOL ................................................................................. 25 
8.2. 
SUBJECTS DISCONTINUED FROM THE STUDY ........................................................... 26 
9. 
DATA ANALYSIS ....................................................................................................... 26 
9.1. 
STUDY ENDPOINTS - EFFICACY ............................................................................... 26 
9.2. 
STUDY ENDPOINTS - SAFETY ................................................................................... 27 
9.3. 
SAMPLE SIZE ........................................................................................................... 28 
10. DRUG INVENTORY AND DISPOSITION .............................................................. 29 
11. STUDY MONITORING .............................................................................................. 29 
12. DOCUMENTS AND NOTIFICATIONS ................................................................... 29 
13. PUBLICATION AND AGREEMENT ....................................................................... 30 
14. INVESTIGATORS AGREEMENT ........................................................................... 30 
15. REFERENCES ............................................................................................................. 31 
 
 


Braintree Laboratories, Inc. 
 
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Protocol Number BLI4700-201 
Version dated 15 JUN 2017 
 
Page 3 of 33 
 
CLINICAL PROTOCOL SUMMARY SHEET 
 
STUDY TITLE:  
A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects 
 
PROTOCOL: 
 
BLI4700-201 
 
VERSION DATE:  15 June 2017  
 
IND NUMBER:  
124,988 
 
STUDY PHASE:   
2 
 
OBJECTIVE:  
To evaluate the safety and efficacy of BLI4700 tablets as a bowel 
preparation prior to colonoscopy in adult patients. 
 
STUDY DESIGN:  This will be an open-label, multi-center study. 
 
SUBJECTS:  
Up to 140 male and female adult subjects will be enrolled. 
 
STUDY  
 
 
MEDICATIONS:  
BLI4700 tablets 
 
 
 
  
 
 
DURATION:  
Subject participation in this study may last up to 37 days. 
 
 
EFFICACY  
 
ENDPOINTS: 
Efficacy will be based on overall preparation success as determined by 
 
the colonoscopist. Additional efficacy measures include the proportion 
of excellent preparations, segmental cleansing, time to cecum, volume of 
intraprocedural water used to improve visualization, percent of 
procedures that reach the cecum. 
 
 
SAFETY 
 
ENDPOINTS: 
Safety endpoints include:  
 
 Adverse event reports 
 Changes in serum chemistry parameters. 
 Subject reported prep-related symptoms 
 
 
 
 
 
 


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Protocol Number BLI4700-201 
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1. INTRODUCTION 
 
Background 
Colorectal cancer (CRC) is a leading cause of cancer death. The lifetime risk of 
developing CRC in the US approaches 6%, and almost half of those affected will die of 
the disease. Despite the usefulness of screening procedures for its detection, CRC is a 
major cause of morbidity and mortality.  In screening procedures for CRC such as 
sigmoidoscopy, colonoscopy, and radiography, it is important that the colon be 
thoroughly purged and cleansed. In particular, it is essential that as much fecal matter 
and fluids as possible be removed from the colon to permit adequate visualization of 
the intestinal mucosa.  
 
 
Preliminary Experience with the Similar Bowel Preparations 
 
Two Phase 3 studies were conducted comparing BLI800 (SUPREP) to the FDA 
approved preparation MoviPrep1. The BLI800-301 study evaluated BLI800 as a one-
day preparation, completed on the day prior to colonoscopy. The BLI800-302 study 
utilized a two-day (or “split-dose”) regimen in which half the preparation was taken the 
evening prior to colonoscopy, and the remaining half completed on the morning of the 
procedure.  
 
The primary efficacy analysis in both Phase 3 studies supported the conclusion that 
BLI800 is equivalent to MoviPrep with respect to cleansing efficacy (cumulative data 
shown below in Table 1). 
 
 
 
 
 
 
 
 
 


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Table 1 
Primary Efficacy Responder Analysis  
BLI800-301/302 Studies 
 
Responder1 
BLI800 
n (%) 
MoviPrep 
n (%) 
95% CI 
p2 
p3 
All Patients (n) 
      Success  
      Fail 
375 
334 (89.5%) 
39 (10.5%) 
376 
330 (87.8%) 
46 (12.2%) 
 
-2.8, 6.3 
 
0.410 
 
<0.001 
301 Patients (n) 
  Success  
  Fail 
194 
159 (82.4%) 
 34 (17.6%) 
193 
155 (80.3%) 
38 (19.7%) 
 
-5.7, 9.8 
 
0.614 
 
<0.001 
302 Patients (n) 
      Success  
      Fail 
181 
175 (97.2%) 
 5 (2.8%) 
183 
175 (95.6%) 
8 (4.4%) 
 
-2.2, 5.4 
 
0.391 
 
<0.001 
 
(1) A successful treatment is defined as bowel cleansing graded either excellent or good by the 
blinded colonoscopist (grading score = 3 or 4).                                             
(2) P-value for the difference between treatments  
(3) P-value for the non-inferiority hypothesis using an equivalence margin of 15 percent 
 
  The breakdown of cleansing efficacy by study and by preparation grade is 
shown below in Table 2. The data indicate that a two day preparation regimen, as 
performed in the 302 study, produces markedly superior cleansing results over a one 
day preparation, as in the 301 study. In each study and overall, BLI800 achieved a 
greater number of excellent preparations than MoviPrep. This difference resulted in a 
higher Mean Preparation Score for BLI800, reaching statistical significance (p = 0.049) 
in the total population.  
 
 
 
 
 
 
 
 
 
 


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Table 2 
Preparation Cleansing Score 
BLI800-301/302 Studies 
 
 
 
All Patients 
 
301 Patients 
 
302 Patients 
 
Score 
SUPREP 
n (%) 
MoviPrep 
n (%) 
SUPREP 
n (%) 
MoviPrep 
n (%) 
SUPREP 
n (%) 
MoviPrep 
n (%) 
4 
Excellent 
200 
(53.6%) 
168 
(44.7%) 
86 
(44.6%) 
72 
(37.3%) 
114 
(63.3%) 
96 
(52.5%) 
3 
Good 
134 
(35.9%) 
162 
(43.1%) 
73 
(37.8%) 
83 
(43.0%) 
61 
(33.9%) 
79 
(43.2%) 
2 
Fair 
25 
(6.7%) 
37 
(9.8%) 
22 
(11.4%) 
31 
(16.1%) 
3 
(1.7%) 
6 
(3.3%) 
1 
Poor 
11 
(2.9%) 
8 
(2.1%) 
9 
(4.7%) 
6 
(3.1%) 
2 
(1.1%) 
2 
(1.1%) 
Mean Score 
3.41 
3.31 
3.24 
3.15 
3.59 
3.47 
p value 
0.049 
0.278 
0.050 
 
Adverse events were also evaluated in the Phase III studies. The only treatment emergent 
adverse event category with a frequency greater than 3% was gastrointestinal (BLI800 = 
4.5% and MoviPrep = 4.3%).  The expected symptoms of nausea and vomiting were the 
most frequent (1.3% each) within the gastrointestinal category.  There was no difference 
between BLI800 and MoviPrep in the frequency of any treatment-emergent adverse 
events, including those that were gastrointestinal in origin.  No clinically significant 
differences between groups were seen in laboratory testing of  serum chemistry and 
hematology. At the one month follow-up visit, no change in serum creatinine was 
observed for BLI800 patients. 
 
A smaller Phase III study (n = 136) was conducted comparing the safety and efficacy of 
SUPREP (in the FDA approved split-dose regimen) to NuLYTELY2. In addition to 
preparation success (as defined above), the blinded colonoscopist also rated the amount of 
residual fluid and stool in each colon segment. As shown below in Tables 3 and 4, 
SUPREP was superior to NuLYTELY in overall preparation success, as well as in 
reducing the amount of residual stool and fluid in most colon segments (most importantly 
the right colon, a segment with higher miss rates for polyps and flat lesions).    
 
 
 


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Table 3 
Primary Efficacy Responder Analysis 
Number and Percent of Successful Preparations 
 
Responder1 
SUPREP 
n  
NuLYTELY 
n  
95% CI 
P2 
All Patients (n) 
     Success  
      Fail 
63 
62 (98.4%) 
 1 (1.6%) 
67 
60 (89.6%) 
7 (10.4%) 
 
0.9, 16.8 
 
0.038 
 
(1) A successful treatment is defined as bowel cleansing graded either excellent or good by the 
blinded colonoscopist (grading score = 3 or 4).                                             
(2) P-value for the difference between treatments  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Table 4 
Investigator Grading of Preparations by Segment 
 
 
Residual Stool 
Residual Fluid 
Symptom (score)  
SUPREP 
(n=63) 
NuLYTELY 
(n=67) 
SUPREP 
(n=63) 
NuLYTELY 
(n=67) 
Cecum 
   Absent 
   Small 
   Moderate 
   Excess 
 
57 (91%) 
6 (9%) 
0 
0 
 
45 (67%) 
15 (22%) 
3 (5%) 
0 
 
27 (43%) 
28 (44%) 
8 (13%) 
0 
 
10 (15%) 
42 (63%) 
10 (15%) 
1 (2%) 
P1 
0.010 
0.004 
Ascending (Right) Colon 
   Absent 
   Small 
   Moderate 
   Excess 
 
57 (91%) 
6 (9%) 
0 
0 
 
46 (69%) 
16 (24%) 
1 (2%) 
0 
 
40 (64%) 
23 (36%) 
0 
0 
 
24 (36%) 
29 (43%) 
10 (15%) 
0 
P1 
0.020 
< 0.001 
Transverse Colon 
   Absent 
   Small 
   Moderate 
   Excess 
 
58 (92%) 
5 (8%) 
0 
0 
 
55 (82%) 
6 (9%) 
1 (2%) 
1 (2%) 
 
43 (68%) 
20 (32%) 
0 
0 
 
33 (49%) 
20 (30%) 
9 (13%) 
1 (2%) 
P1 
0.644 
0.005 
Descending Colon 
   Absent 
   Small 
   Moderate 
   Excess 
 
58 (92%) 
5 (8%) 
0 
0 
 
56 (84%) 
6 (9%) 
1 (2%) 
0 
 
42 (67%) 
17 (27%) 
4 (6%) 
0 
 
26 (39%) 
32 (48%) 
5 (8%) 
0 
P1 
0.763 
0.013 
Sigmoid Colon/Rectum 
   Absent 
   Small 
   Moderate 
   Excess 
 
59 (94%) 
3 (5%) 
1 (1%) 
0 
 
54 (81%) 
7 (10%) 
3 (5%) 
2 (3%) 
 
40 (64%) 
20 (32%) 
3 (5%) 
0 
 
32 (48%) 
28 (42%) 
5 (8%) 
0 
P1 
0.173 
0.283 
1P-value for difference between treatments  
 
 
 


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There were no deaths or serious adverse events for patients who received SUPREP in 
this study. No statistically significant differences between the preparations with respect 
to adverse events were detected in the elderly population or overall.  The number of 
events expected with gastrointestinal cleansing agents (e.g. nausea, bloating and 
cramping) was insignificant. Differences in laboratory results were considered by 
investigators to be clinically insignificant.  
 
The BLI800-301 and BLI800-302 studies supported the FDA’s determination that 
SUPREP was safe and effective in adults undergoing colonoscopy, leading to its FDA  
approval in August 2010.  
 
As a condition of the SUPREP approval, FDA required Braintree Laboratories to 
conduct several post marketing studies in order to further demonstrate the safety of 
SUPREP in special populations (the elderly, and those with renal or hepatic 
impairment) and to look for rare occurring serious adverse events. In study BLI800-
440 (PMR 1580-7), patients in special populations (renal/hepatic/elderly) took 
SUPREP prior to colonoscopy and were followed for 6 months. 184 patients took 
SUPREP in this study, which also included non-special population patients (e.g. 
patients undergoing screening colonoscopy). SUPREP was shown to be safe in all of 
these patient groups in near term and long term follow up, comparable to the 
GoLYTELY comparator used in the study.  
 
Studies BLI800-430 and BLI800-431 (PMR 1580-8) evaluated the safety of SUPREP 
in special populations (renal/hepatic/elderly) through repeated ECG measurements. A 
total of 37 patients completed the study and no significant ECG changes were seen 
after patients took two SUPREP doses 2 hours apart (acute administration).  
 
For study BLI800-450 (PMR 1580-6), a large retrospective review of electronic 
medical records and insurance claims was conducted to tabulate the rates of specific 
serious adverse events (e.g. cardiac events, rental failure, ischemic colitis) occurring 
within 3 months of patients taking SUPREP. Claims data on approximately 33,000 


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SUPREP patients and 266,000 control patients was analyzed, revealing no difference 
between groups for serious adverse events of interest.    
Preliminary Development of BLI4700 
  


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The goal of the current study is to evaluate the safety and efficacy of a modified 
BLI4700 tablet formulation in adult patients.  
2. STUDY OBJECTIVE
The objective of this study is to evaluate the safety and efficacy of BLI4700 as a bowel 
preparation prior to colonoscopy in adult patients. 
3. STUDY PLAN
3.1. Study Design 
This is an open-label, multi-center study in adult subjects. 
3.2. Number of Subjects 
Up to 140 male and female subjects who are undergoing colonoscopy for routinely 
accepted indications will be enrolled in this study. Enrollment will continue until up to 
140 subjects have undergone a colonoscopy. Approximately 25% of subjects must 
have a recent history (within a year) of constipation. 
3.3. Duration of Study 
Subject participation in this study will last up to 37 days. A screening visit (Visit 1) 
should be performed within 30 days of the colonoscopy. Subjects meeting all eligibility 


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criteria will be enrolled to receive BLI4700. Subjects will return to the clinic the day of 
colonoscopy (Visit 2). Subjects with clinically significant laboratory abnormalities and/or 
ongoing adverse events related to the study preparation may return for a follow up visit 7 
days after colonoscopy.   
3.4. Study Preparations 
Multiple preparation formulations will be evaluated in this trial. The active ingredients 
and amounts contained in each BLI4700 tablet preparation are shown in the table 
below.     
BLI4700 Formulation Summary 
(Amount in 24 tablets) 
 Ingredient 
Version 1 
Version 2 
Version 3 
Version 4 
Version 5 
Sodium Sulfate 
Potassium Sulfate 
Potassium Chloride 
Potassium 
Bicarbonate 
Magnesium Sulfate 
Magnesium Citrate 
Magnesium Chloride 
For each formulation, subjects will consume a total of 24 tablets (two 12 tablet doses). 
Each tablet dose will be contained in a separate bottle. The bottles will have a clinical 
label containing a caution statement, study code, study sponsor and kit number. 
Subjects will be provided with instructions on how to complete the preparation.  
Any additional formulations evaluated under this protocol will require a formal 
amendment and IRB approval prior to enrollment of subjects. 


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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 outpatients who are undergoing colonoscopy for a routinely 
accepted indication, including (but not limited to):  
 
 
Routine screening 
 
Polyp or neoplasm history 
 
Rectal bleeding 
 
Other gastrointestinal bleeding 
 
Abdominal pain 
 
Unknown diarrhea or constipation etiology 
 
Anemia of unknown etiology 
 
Inflammatory bowel disease 
 
Abnormal endosonography 
 
Evaluation of barium enema results  
 
Laser therapy 
 
2. Have previously had a colonoscopy performed 
 
3. At least 18 years of age 
 
4. Subjects must be scheduled for a morning colonoscopy (prior to 12:00PM) 
 
5. If female, and of child-bearing potential, is using an acceptable form of birth 
control (hormonal birth control, IUD, double-barrier method, depot contraceptive, 
abstinent, or vasectomized spouse). Subjects practicing abstinence must agree to 
use an acceptable form of birth control should they become sexually active during 
the study.  Pharmacologic methods of contraception must be stable for at least one 
month prior to Visit 1 and remain stable though completion of the study. 
 
6. Negative urine pregnancy test at screening, if applicable 
 
7. In the Investigator’s judgment, subject is mentally competent to provide informed 
consent to participate in the study 
 
 
 
3.5.2. Exclusion Criteria  
Subjects who meet any of the following criteria will be excluded from the study: 
 
1. Subjects with dysphagia or an aversion to swallowing tablets.  
 
2. Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal 
obstruction, gastric retention, bowel perforation, toxic colitis or megacolon. 


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3.
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.
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, dehydration, or those secondary to the use of diuretics or
angiotensin converting enzyme (ACE) inhibitors.
5.
Subjects with a prior history of renal, liver or cardiac insufficiency (including congestive 
heart failure or other significant cardiac abnormality) that the
investigator feels is clinically significant and should rule out the subject from 
participation in the study.
6.
Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
7.
Subjects undergoing colonoscopy for foreign body removal and/or decompression.
8.
Subjects who are pregnant or lactating, or intending to become pregnant during the study.
9.
Subjects of childbearing potential who refuse a pregnancy test.
10. Subjects allergic to any preparation components.
11. Subjects who, in the opinion of the Investigator, should not be included in the study
for any reason, including inability to follow study procedures.
12. Subjects who have participated in an investigational surgical, drug, or device study 
within the past 30 days.
13. Subjects who withdraw consent before completion of Visit 1 procedures.
4. STUDY PROCEDURES
Study procedures are described as follows and depicted graphically in Section 4.5, 
below. 
4.1. Visit 1 
Following the informed consent process, the subjects will sign a consent form. 
Subject’s demographics and concomitant medications will be recorded, vital signs will 


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be obtained (including height (visit 1 only), weight, pulse, orthostatic blood pressure), 
and a physical examination will be performed. 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, Diabetes, Cancer (must indicate type of cancer), Electrolyte 
abnormalities 
Blood samples will be collected for testing.  Colonoscopies must be scheduled to allow 
for receipt of laboratory results prior to the day the subject is scheduled to begin 
preparation.  
 
Serum Chemistry: Alkaline Phosphatase, ALT, anion gap (calculated), AST, 
bicarbonate, total bilirubin, blood urea nitrogen, calcium, chloride, creatinine 
kinase, creatinine, eGFR (calculate), GGT, magnesium, phosphorus, potassium, 
sodium, total protein and uric acid  
 
A urine pregnancy test will be performed on female subjects of childbearing potential 
(see Section 4.7). Subjects meeting all entry criteria will be eligible for enrollment. 
4.1.1. Study Drug 
Eligible subjects will be provided with instructions on how to use the study 
preparation. Subjects will self-administer the study preparation starting on the day prior 
to their scheduled colonoscopy according to the instructions provided by the study site 
(full preparation instructions are included in Appendix A). 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. Subjects must be notified and instructed to return their unopened bowel 
preparation to the study center.  These subjects will be classified as screen failures.    
Returned un-used study drug kits will not be re-dispensed to another subject.    


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4.1.2. Dietary Restrictions 
Subjects may have a low residue breakfast on the day before colonoscopy, followed by 
clear liquids until the colonoscopy is completed the following day. Examples of 
acceptable low residue items are found in the preparation instructions. 
 
Examples of acceptable clear liquids are provided 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. 
4.1.3. Subject Questionnaires 
 
Subjects will be provided with a Preparation Questionnaire and Dietary Questionnaire 
to report document their preparation and dietary intake (refer to Appendix B for full 
questionnaires). Subjects will complete these questionnaires starting on the morning 
they are scheduled to take their first dose of each preparation (Preparation Day 1) until 
they return to the study center the following day (Preparation Day 2). The time of 
food/fluid ingestion will be recorded. Site staff must review the descriptions and times 
recorded on the questionnaire at Visit 2 to confirm that subjects were compliant with 
the dietary restrictions outlined in Section 4.1.2. 
4.2. Bowel Preparation Administration 
On the day prior to their appointment, subjects will begin following the protocol 
specified dietary restrictions (as outlined in Section 4.1.2) and completing their 
Preparation and Dietary Questionnaires (refer to Appendix B). In the evening, subjects 
will begin consuming their bowel preparation according to the instructions provided by 


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the study center (refer to Appendix A). Subjects will take the second dose of bowel 
preparation the following morning.   
4.3. Visit 2 
Subjects 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 will bring back their questionnaires and study personnel will review the 
questionnaires for completeness so that any missed responses can be captured. Subjects 
will complete a preference questionnaire. Any violations of the dietary restrictions 
must be confirmed with the subject. 
 
Subject’s vital signs 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 samples will be collected for chemistry testing.  
 
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 4.6.   The 
colonoscopy procedure will be video recorded through the endoscope.  
 
4.3.1. Symptom Scale 
 
At Visit 2 (prior to sedation), subjects will complete a form asking them to report their 
experience with the preparation for the most frequently occurring bowel preparation 
symptoms of stomach cramping, stomach bloating, nausea and vomiting. Symptoms will 
be rated as none (no symptom), mild, bothersome, distressing or severely distressing.  
 


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4.3.2. Drug Accountability 
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. The staff members will perform drug 
accountability by counting any remaining BLI4700 tablets.  
 
Returned study preparation materials must be accounted for on drug inventory log and will 
be returned to the Sponsor at the completion or termination of the study, unless instructed 
otherwise by the Sponsor. 
 
 
4.4. Follow up of Adverse Events and Laboratory Results 
Subjects who have ongoing adverse events related to the study preparation (except for 
those expected symptoms for which the subjects are prompted in their questionnaire) or 
abnormal laboratory values from Visit 2 blood draws that the investigator feels are 
clinically significant will return approximately 7 days following colonoscopy. Subjects 
with prior clinically significant abnormal laboratory values should undergo repeat 
testing. Subjects returning due to ongoing adverse events related to study preparation 
should be assessed to determine if the event has resolved or is clinically stable.  


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4.5. Tabulated Study Procedures 
The following graphically depicts the flow of study procedures at each visit. 
 Procedures 
Visit 1 
Screening 
Day before 
colonoscopy 
Visit 2 
Day of 
colonoscopy 
Informed Consent 
X 
 
 
Inclusion/Exclusion Criteria Review 
X 
 
 
Medical History 
X 
 
 
Physical Examination / Vital Signs 
X 
 
X 
Review of Concomitant Medication 
X 
 
X 
Blood Collection for Laboratory Testing 
X 
 
X 
Urine Pregnancy Test (if applicable) 1 
X 
 
 
Dispense Drug  
X 
 
 
Instruct Subject 
X 
 
 
Dispense Preparation Questionnaire 
X 
 
 
Subject Takes the 1st  Dose of Preparation 
 
X 
 
Subject Completes Preparation 
Questionnaire  
 
X 
X 
Subject Takes the 2nd  Dose of Preparation  
 
 
X 
Subject Completes Symptom Scale and 
Preference Questionnaire2 
 
 
X 
Drug Accountability 
 
 
X 
Colonoscopy performed with Intra-
procedural Safety and Efficacy Grading3 
 
 
X 
Collect and assess adverse event data4 
 
 
X 
1 refer to Section 4.7  
2to be dispensed and completed at Visit 2, prior to colonoscopy 
 
3All colonoscopies will be recorded for transmission to sponsor 
 
4Subjects with ongoing preparation-related AEs/clinically significant lab results may need to return on follow up Day 7 


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4.6 Physician Assessments 
4.6.1. Segmental Cleansing Assessment 
During the exam, the colonoscopist will rate each colon segment (proximal, mid, 
distal) using the following scale: 
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 
 
 
 
4.6.2. Overall Cleansing Assessment 
Following completion of the procedure, the 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 4.6.1.   
 
4.6.3. Additional Efficacy Measures 
 
In addition, the following data will be collected: 
1. Adequacy of preparation according to the 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. 


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4. Completion time of colonoscopy. 
5. Volume of water used to improve visualization. 
 
4.7. Pregnancy 
Subjects that are female and of childbearing potential must have a urine pregnancy 
test done at screening. A positive result will rule out the participation of the subject 
in the study. 
 
Female study subjects must be surgically sterilized or use oral contraceptives, depot 
contraceptives, double-barrier method, intrauterine device, or testify that she is 
monogamous with a vasectomized partner, 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. Women who are post-menopausal (as defined in this section), or have had 
a partial or total hysterectomy or tubal ligation are not considered of child bearing 
potential. 
 
Oral contraceptives, hormone implants, and injections should be stable for at least 1 
month before the study, until completion of the study.  Subjects are not allowed to 
change their birth control method during the course of the study. 
 
Menopausal status is defined when menses have been absent for 12 months in a 
woman of appropriate age (usually 45 to 55 years) who has no other suspected or 
identified cause of amenorrheaas. 
 
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.  
 


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4.8. Concomitant Medications 
The use of concomitant medication will be recorded from 7 days prior to screening until 
completion the study, including intravenous fluids administered during colonoscopy.  
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. Symptoms on the 
symptom scale rated as 2 (mild) to 5 (severely distressing) must be reported as an 
adverse event. 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. Subjects that have an ongoing treatment emergent adverse event or 
clinically significant abnormal laboratory value will be followed up approximately 
one week after colonoscopy.  
 
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. 
 
 
 
 
 


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5.2 
Expected Adverse Events 
 
Because BLI4700 tablets contain the same active ingredient (sodium sulfate) as 
SUPREP, a similar adverse event profile is expected. In Phase 3 clinical trials, 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.  
 
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 colonoscopy. Pre-scheduled 
surgeries 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.  


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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. 
Any serious and/or unexpected adverse events that occur during the study 
will be reported to Braintree Laboratories as follows: 
Contact Telephone Numbers: 
During Business hours 
(M-F, 8:30 am – 5:00 pm EDT) 
After hours or weekends 
Braintree Laboratories and its medical monitor will review the report and determine 
whether an FDA Form 3500A will also be completed and sent to FDA. 
7. INSTITUTIONAL REVIEW BOARD (IRB) AND INFORMED
CONSENT
IRB review and approval of the study protocol and Informed Consent Form will be 
obtained prior to initiation of the study.  Amendments to the study protocol and consent 
form generated during the course of the study will also require IRB approval. 
8. MANAGEMENT OF INTERCURRENT EVENTS
8.1. Modification of Protocol 
Investigators may request an exemption from Braintree Laboratories to enroll a 
subject with questionable eligibility or to continue a subject with a protocol 
violation. Exemptions must be faxed to Braintree using the designated form and 
approved before any action is taken. Note that eligibility criteria exemptions may 
require pre-approval from the Institutional Review Board. Investigators that 
continually violate the protocol or commit a serious violation may be subject to 
termination from the study. The study may be halted if at any time an Investigator or 


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Braintree Laboratories deems the incidence or severity of adverse events to be 
unacceptable. 
 
8.2. Subjects Discontinued from the Study 
Subjects may be dropped from the study for any of the following reasons: 
 An adverse event requiring discontinuation (including failure to tolerate study 
medication). 
 Female participants who become pregnant during the study period. 
 Major protocol deviation from the study design by the subject that is observed or 
suspected by the Investigator 
 Subject chooses to withdraw from the study, for whatever reason. 
 Subject is lost to follow-up. 
 The Sponsor initiates an early discontinuation of the study. 
 The subject is withdrawn at the discretion of the Investigator. 
 
Braintree should be contacted if possible prior to discontinuation of any subject. 
 
 
9. DATA ANALYSIS 
9.1. Study Endpoints - Efficacy 
Primary efficacy will be assessed on the basis of a binary outcome of overall 
preparation success or failure. The following definition of preparation success and 
failure will be used: 
 
Definition of successful preparation:  
1. Overall Cleansing Assessment by the colonoscopist (Section 4.6.2) 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. 


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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. 
 
Additional efficacy endpoints will include: 
 Number (%) of excellent preparations overall and by segment 
 Adequacy of cleaning and need for re-preparation 
 Duration of colonoscopy 
 Volume of intraprocedural water needed to irrigate the colon  
 Number (%) of procedures that reached the cecum 
 Time to cecum 
 
9.2. Study Endpoints - Safety 
Adverse Events: 
All subjects who took preparation in any amount will be included in the safety 
analysis. All adverse events will be summarized 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. 
 
In order to define treatment emergence for events with missing start or stop dates the 
following additional criteria will be used: 


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 
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.   
 
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) will be 
summarized with descriptive statistics. 
 
Symptom Questionnaire Data: 
Symptom questionnaire data for individual symptoms for Overall Experience 
(Stomach Cramping, Stomach Bloating, Nausea and Vomiting) will be presented. 
 
9.3. Sample Size  
Up to   80 subjects will be enrolled and treated in the study.  This size was chosen 
because of the pilot nature of this study. 
 


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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 the subjects by study personnel and 
will be kept on file at the study center. 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 data collection forms for each subject. Subject 
medical records will be reviewed to verify all other data points, including potential 
adverse events.  Copies of subjects’ laboratory reports, colonoscopy and pathology 


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reports (if applicable) will be collected for Braintree Laboratories after subject 
identifiers have been redacted by site staff. Each colonoscopy will be recorded and 
transmitted to Braintree Laboratories. The Investigator should retain copies of the 
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 BLI4700, 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.  
 
13. PUBLICATION AND AGREEMENT 
 
The results of this study will be published if mutually agreed by Braintree 
Laboratories and the Investigator and at a mutually agreed upon date. Investigator 
agrees to submit to Braintree Laboratories, within sixty (60) days of the proposed 
submission date, any proposed publication or presentation for prior review.  
Braintree Laboratories will, within thirty (30) days after receipt, advise if there is any 
proprietary or patentable information, which should not be disclosed at the present 
time. Investigator shall not release any such proposed publication or presentation, if 
so notified by Braintree Laboratories. 
14. INVESTIGATORS AGREEMENT   
 
I agree to perform the protocol according to Federal Regulations and as detailed in 
this document to the best of my ability.  I recognize that if I fail to do so my 
participation in this study may be terminated.  I also agree to the publication 
provisions stated in Section 13, above. My signature on the cover page of this 
protocol serves as documentation of my acceptance of the terms noted above. 
 


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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 - Markowitz GS, Stokes MB, Radhakrishnan J, D'Agati VD. Acute phosphate 
nephropathy following oral sodium phosphate bowel purgative: an underrecognized 
cause of chronic renal failure J Am Soc Nephrol.2005; 16(11):3389-96. 
 
4 - Davis GR, Santa Ana CA, Morawski SG, Fordtran JS. Development of a lavage 
solution associated with minimal water and electrolyte absorption or secretion.  
Gastroenterology. 1980 May;78(5 Pt 1):991-5.  
 
5 - DiPalma JA, Marshall JB. Comparison of a new sulfate-free polyethylene glycol 
electrolyte lavage solution versus a standard solution for colonoscopy cleansing. 
Gastrointestinal Endoscopy.1990;36:285-289. 
 
6 - DiPalma JA, Wolff BG, Meagher A, Cleveland MvB. Comparison of reduced 
volume versus four liters sulfate-free electrolyte lavage solutions for colonoscopy 
colon cleansing. Amer. J. Gastro.2003;98:2187-2191. 
 
 
 
 
 
 


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APPENDIX A: PREPARATION INSTRUCTIONS 


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APPENDIX B: PATIENT QUESTIONNAIRES