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Phase 2 N=114 Treatment

A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects

Colonoscopy

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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