Phase 2
N=114
A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects
Colonoscopy
Bottom Line
View on ClinicalTrials.gov: NCT03023085 ↗Enrolled (actual)
114
Serious AEs
0.9%
Results posted
Nov 2023
Primary outcome: Primary: Number and Percentage of Subjects With Successful Bowel Cleansing — 35; 36; 16; 19 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BLI4700 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Braintree Laboratories
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Percentage of Subjects With Successful Bowel Cleansing |
35; 36; 16; 19 | — |
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.
Eligibility Criteria
Key Inclusion Criteria
- Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
- Have previously had a colonoscopy performed
- At least 18 years of age
- Subjects must be scheduled for a morning colonoscopy (prior to 12:00PM)
- If female, and of child-bearing potential, is using an acceptable form of birth control.
- 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
Key Exclusion Criteria
- Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
- 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 a prior history of renal, liver or cardiac insufficiency
- 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.
Data sourced from ClinicalTrials.gov (NCT03023085). 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.