A Pilot Evaluation of BLI4900 Bowel Preparation in Adult Subjects

Colonoscopy Clinical Trial

Official title:

A Pilot Evaluation of BLI4900 Bowel Preparation in Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03328507
• Other study ID #: BLI4900-201
• Status: Completed
• Phase: Phase 2
• Start date: November 9, 2017
• Est. completion date: November 12, 2019

Study information

• Verified date: September 2023
• Source: Braintree Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: November 12, 2019
• Est. primary completion date: November 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• BLI4900
BLI4900 Bowel Preparation
• PEG Control
Polyethylene glycol-based bowel preparation

Locations

Country	Name	City	State
United States	Braintree Research Site 1	Anaheim	California
United States	Braintree Research Site 3	Chula Vista	California
United States	Braintree Clinical Research Site 2	Ogden	Utah
United States	Braintree Research Site 4	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Braintree Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of Subjects With Successful Bowel Preparation	% of subjects with successful bowel preparation rated by blinded colonoscopist on a 4 point scale (1=poor to 4 = excellent)	Day of colonoscopy