Study 301: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy

Colonoscopy Clinical Trial

Official title:

A Safety and Efficacy Comparison of BLI4900 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04446299
• Other study ID #: BLI4900-301
• Status: Completed
• Phase: Phase 3
• Start date: July 13, 2020
• Est. completion date: January 22, 2021

Study information

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

Clinical Trial Summary

The purpose of this study is to compare the safety and efficacy of BLI4900 bowel preparation to an FDA-approved control as 2-day, split-dose bowel preparations prior to colonoscopy in adult patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 519
• Est. completion date: January 22, 2021
• Est. primary completion date: December 22, 2020
• 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.

• Negative serum 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, gastrointestinal obstruction, gastroparesis, gastric retention, bowel perforation, toxic colitis or megacolon.

• Subjects with inflammatory bowel disease who have a history of any bowel resection (small intestine or colon), suspected active inflammation, or symptoms suggestive of obstruction or known bowel stricture.

• Subjects who had previous significant gastrointestinal surgeries.

• Subjects who have regularly used laxatives or colon motility altering drugs in the last month (i.e. more than 2-3 times per week) and/or laxative use within 72 hours prior to administration of the preparation

• Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.

• Subjects taking diuretics, anti-hypertensive medications, including angiotensin converting enzyme (ACE) inhibitors and Angiotensin II receptor blockers (ARBs), or chronic NSAIDs, that have not been stable for 30 days.

• Subjects with uncontrolled hypertension.

• Subjects taking antibiotics within 7 days of colonoscopy.

• Subjects with severe renal, hepatic or cardiac insufficiency.

• Subjects with an abnormal and clinically significant physical examination or ECG finding at Visit 1.

• 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 taking tricyclic antidepressants.

• Subjects using drugs of abuse, including abused prescription medications.

• Subjects who are withdrawing from alcohol or benzodiazepines.

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• Bowel Prep
Orally ingested liquid bowel preparation

Locations

Country	Name	City	State
United States	301 Research Site 15	Brooklyn	New York
United States	301 Research Site 13	Chesterfield	Missouri
United States	301 Research Site 16	Clearwater	Florida
United States	301 Research Site 2	Decatur	Georgia
United States	301 Research Site 11	Flowood	Mississippi
United States	301 Research Site 5	Great Neck	New York
United States	301 Research Site 20	Hixson	Tennessee
United States	301 Research Site 18	Huntsville	Alabama
United States	301 Research Site 10	Indianapolis	Indiana
United States	301 Research Site 12	Jacksonville	Florida
United States	301 Research Site 21	Mentor	Ohio
United States	301 Research Site 22	Milwaukee	Wisconsin
United States	301 Research Site 3	Monroe	Louisiana
United States	301 Research Site 23	New York	New York
United States	301 Research Site 1	Ogden	Utah
United States	301 Research Site 9	Palm Harbor	Florida
United States	301 Research Site 4	Palmetto Bay	Florida
United States	301 Research Site 26	Port Orange	Florida
United States	301 Research Site 6	Raleigh	North Carolina
United States	301 Research Site 19	Reno	Nevada
United States	301 Research Site 14	Saint Petersburg	Florida
United States	301 Research Site 7	San Diego	California
United States	301 Research Site 17	Shreveport	Louisiana
United States	301 Research Site 24	Sun City	Arizona
United States	301 Research Site 25	Sunrise	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Braintree Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Subjects With Successful Bowel Preparation	Successful bowel preparation is defined as a preparation rated as Excellent or Good by the blinded endoscopist on a 4 point scale (Excellent, Good, Fair, Poor).	2 days