Clinical trial NCT03261960: A Safety and Efficacy Comparison of BLI4700 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
Official title: A Safety and Efficacy Comparison of BLI4700 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colonoscopy
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2017-08-25
Enrollment: 389
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare the safety and efficacy of BLI4700 bowel preparation to an FDA-approved bowel preparation as 2-day, split-dose bowel preparations prior to colonoscopy in adult patients.


Eligibility criteria: Inclusion Criteria:

* Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
* 18 to 85 years of age (inclusive)
* 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).
* Negative serum pregnancy test at screening, if applicable
* In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria:

* Subjects with known or suspected ileus, gastrointestinal obstruction, gastroparesis, gastric retention, bowel perforation, toxic colitis or megacolon.
* Subjects with ongoing severe, acute inflammatory bowel disease
* Subjects who had previous significant gastrointestinal surgeries.
* Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
* Subjects taking diuretics, anti-hypertensive medications, including angiotensin converting enzyme (ACE) inhibitors and Angiotensin II receptor blockers (ARBs), or chronic NSAIDs, that have not been stable for 30 days. NSAID use for occasional pain is not exclusionary.
* Subjects with uncontrolled hypertension (systolic blood pressure \> 170 mmHg and diastolic blood pressure \> 100 mmHg).
* Subjects taking antibiotics within 7 days of colonoscopy.
* Subjects with severe renal insufficiency (GFR \< 30 mL/min/1.73m2).
* Subjects with known severe hepatic insufficiency (Child Pugh C)
* Subjects with cardiac insufficiency (NYHA Functional Classifications 3 or 4).
* Subjects with an abnormal and clinically significant physical examination or ECG finding at Visit 1.
* Subjects undergoing insulin therapy for any indication.
* Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
* Subjects undergoing colonoscopy for foreign body removal and/or decompression.
* Subjects who are pregnant or lactating, or intending to become pregnant during the study.
* Subjects of childbearing potential who refuse a pregnancy test.
* Subjects allergic to any preparation component.
* Subjects using drugs of abuse, including abused prescription medications.
* Subjects who are withdrawing from alcohol or benzodiazepines.
* Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
* Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.

Primary outcomes:
measure: Number and Percentage of Subjects With Successful Bowel Cleansing
timeFrame: Day of colonoscopy
Secondary outcomes:
Other outcomes:
measure: Abdominal Pain (Solicited Reports)
timeFrame: 2 days
measure: Abdominal Distension (Solicited Reports)
timeFrame: 2 days
measure: Nausea (Solicited Reports)
timeFrame: 2 days
measure: Vomiting (Solicited Reports)
timeFrame: 2 days
Locations:
city: Dothan
country: United States
facility: Braintree Research Site 119
state: Alabama
city: Tucson
country: United States
facility: Braintree Research Site 117
state: Arizona
city: Little Rock
country: United States
facility: Braintree Research Site 108
state: Arkansas
city: Little Rock
country: United States
facility: Braintree Research Site 110
state: Arkansas
city: Palmetto Bay
country: United States
facility: Braintree Research Site 139
state: Florida
city: Oak Lawn
country: United States
facility: Braintree Research Site 124
state: Illinois
city: Indianapolis
country: United States
facility: Braintree Research Site 134
state: Indiana
city: Chevy Chase
country: United States
facility: Braintree Research Site 112
state: Maryland
city: Towson
country: United States
facility: Braintree Research Site 141
state: Maryland
city: Chesterfield
country: United States
facility: Braintree Research Site 125
state: Missouri
city: Saint Louis
country: United States
facility: Braintree Research Site 102
state: Missouri
city: Egg Harbor Township
country: United States
facility: Braintree Research Site 145
state: New Jersey
city: Poughkeepsie
country: United States
facility: Braintree Research Site 114
state: New York
city: Asheville
country: United States
facility: Braintree Research Site 105
state: North Carolina
city: Charlotte
country: United States
facility: Braintree Research Site 115
state: North Carolina
city: Raleigh
country: United States
facility: Braintree Research Site 137
state: North Carolina
city: Raleigh
country: United States
facility: Braintree Research Site 101
state: North Carolina
city: Greenville
country: United States
facility: Braintree Research Site 107
state: South Carolina
city: Charlottesville
country: United States
facility: Braintree Research Site 131
state: Virginia
city: Bellevue
country: United States
facility: Braintree Research Site 121
state: Washington
Study officials:
affiliation: Braintree Laboratories, Inc.
name: John McGowan, MPH
role: STUDY_DIRECTOR
References: