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Phase 2 N=121 Treatment

A Pilot Evaluation of BLI4900 Bowel Preparation in Adult Subjects

Colonoscopy

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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