A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects

NCT03023085 | Completed Phase 1 Results

• 1 other identifier: BLI4700-201
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

BLI4700

EXPERIMENTAL

BLI4700 Bowel Preparation

Drug: BLI4700

Interventions

BLI4700 DRUG

BLI4700 bowel preparation

BLI4700

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Braintree Laboratories: lead

Study Sites (1)

Braintree Research Site 1

Anaheim, California, United States

Location

Results Point of Contact

• Title: Head of R&D, Gastroenterology
• Organization: Braintree Laboratories, Inc.

studydirector@sebelapharma.com

781-843-2202

Study Officials

• John McGowan, MPH

  Braintree Laboratories, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 18, 2017
• Study Start: August 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: November 15, 2023
• Results First Posted: November 15, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)