Phase 2
N=121
A Pilot Evaluation of BLI4900 Bowel Preparation in Adult Subjects
Colonoscopy
Bottom Line
View on ClinicalTrials.gov: NCT03328507 ↗Enrolled (actual)
121
Serious AEs
0.8%
Results posted
Oct 2023
Primary outcome: Primary: % of Subjects With Successful Bowel Preparation — 17; 37; 37; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BLI4900 (Drug); PEG Control (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Braintree Laboratories
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY % of Subjects With Successful Bowel Preparation |
17; 37; 37; 16 | — |
Summary
The objective of this study is to evaluate the safety and efficacy of BLI4900 as a bowel preparation 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 urine 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, severe ulcerative colitis, gastrointestinal obstruction, 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 with uncontrolled hypertension (systolic blood pressure > 170 mmHg and diastolic blood pressure > 100 mmHg).
- 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 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 components.
- 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.
- Subjects who withdraw consent before completion of Visit 1 procedures.
Data sourced from ClinicalTrials.gov (NCT03328507). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.