A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects

The objective of this study is to evaluate the safety and efficacy of BLI4700 as a bowel preparation prior to colonoscopy in adult patients.

Study Overview

• Status: Completed
• Conditions: Colonoscopy
• Intervention / Treatment: Drug: BLI4700

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States
      • Braintree Research Site 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BLI4700; BLI4700 Bowel Preparation	Drug: BLI4700; BLI4700 bowel preparation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Frequency of adverse events	7 days

Collaborators and Investigators

• Sponsor: Braintree Laboratories
• Investigators: Study Director: John McGowan, MPH, Braintree Laboratories, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: January 13, 2017
• First Submitted That Met QC Criteria: January 13, 2017
• First Posted (Estimated): January 18, 2017

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: BLI4700-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO