A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects

Phase 1

Completed

• Conditions: Colonoscopy
• Interventions: Drug: BLI4700

• Registration Number: NCT03023085
• Lead Sponsor: Braintree Laboratories

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2017-01-13
• Study First Submitted QC: 2017-01-13
• Study First Posted: 2017-01-18
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Disposition First Submitted: 2018-09-26
• Disposition First Submitted QC: 2018-09-26
• Disposition First Posted: 2018-09-28
• Results First Submitted: 2023-09-29
• Status Verified: 2023-10
• Results First Submitted QC: 2023-10-25
• Last Update Submitted: 2023-10-25
• Results First Posted: 2023-11-15
• Last Update Posted: 2023-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
2. Have previously had a colonoscopy performed
3. At least 18 years of age
4. Subjects must be scheduled for a morning colonoscopy (prior to 12:00PM)
5. If female, and of child-bearing potential, is using an acceptable form of birth control.
6. Negative urine pregnancy test at screening, if applicable
7. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Key

Exclusion Criteria

1. Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
2. Subjects who had previous significant gastrointestinal surgeries.
3. Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
4. Subjects with a prior history of renal, liver or cardiac insufficiency
5. Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
6. Subjects undergoing colonoscopy for foreign body removal and/or decompression.
7. Subjects who are pregnant or lactating, or intending to become pregnant during the study.
8. Subjects of childbearing potential who refuse a pregnancy test.
9. Subjects allergic to any preparation components.
10. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
11. Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BLI4700	BLI4700	BLI4700 Bowel Preparation

Primary Outcome Measures

Name	Time	Method
Number and Percentage of Subjects With Successful Bowel Cleansing	Day of colonoscopy	% of subjects with successful bowel preparation rated by blinded colonoscopist on a 4 point scale (1=poor, 2=fair, 3=good, 4 = excellent)

Trial Locations

Locations (1)

Braintree Research Site 1; 🇺🇸 Anaheim, California, United States