A Safety and Efficacy Comparison of BLI4700 Bowel Prep Versus an FDA-approved Comparator in Adults Prior to Colonoscopy

Phase 3

Completed

• Conditions: Colonoscopy
• Interventions: Drug: BLI4700; Drug: Polyethylene glycol bowel preparation

• Registration Number: NCT03404401
• Lead Sponsor: Braintree Laboratories

Brief Summary

The objective of this study is to compare the safety and efficacy of BLI4700 bowel preparation to an FDA-approved bowel preparation as 2-day, split-dose bowel preparations prior to colonoscopy in adult patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-11
• Study First Submitted: 2018-01-12
• Study First Submitted QC: 2018-01-12
• Study First Posted: 2018-01-19
• Primary Completion: 2018-07-10
• Study Completion: 2018-07-10
• Disposition First Submitted: 2019-09-27
• Status Verified: 2021-05
• Results First Submitted: 2021-05-04
• Results First Submitted QC: 2021-08-12
• Disposition First Submitted QC: 2021-08-12
• Last Update Submitted: 2021-08-12
• Results First Posted: 2021-09-08
• Disposition First Posted: 2021-09-08
• Last Update Posted: 2021-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 620

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 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 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. NSAID use for occasional pain is not exclusionary.
• Subjects with uncontrolled hypertension (systolic blood pressure > 170 mmHg or diastolic blood pressure > 100 mmHg).
• Subjects taking antibiotics within 7 days of colonoscopy.
• 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 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 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 component.
• Subjects using drugs of abuse, including abused prescription medications.
• Subjects who are withdrawing from alcohol or benzodiazepines.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BLI4700 Bowel Preparation	BLI4700	-
FDA Approved Bowel Preparation	Polyethylene glycol 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 colonoscopist on a 4 point scale (1=poor to 4=excellent)

Trial Locations

Locations (23)

Braintree Research Site 219; 🇺🇸 Chula Vista, California, United States

Braintree Research Site 223; 🇺🇸 Lake Charles, Louisiana, United States

Braintree Research Site 211; 🇺🇸 Monroe, Louisiana, United States

Braintree Research Site 224; 🇺🇸 Atlanta, Georgia, United States

Braintree Research Site 212; 🇺🇸 Mobile, Alabama, United States

Braintree Research Site 209; 🇺🇸 Anaheim, California, United States

Braintree Research Site 215; 🇺🇸 Decatur, Georgia, United States

Braintree Research Site 206; 🇺🇸 Los Angeles, California, United States

Braintree Research Site 207; 🇺🇸 Hagerstown, Maryland, United States

Braintree Research Site 210; 🇺🇸 Great Neck, New York, United States

Braintree Research Site 220; 🇺🇸 San Diego, California, United States

Braintree Research Site 214; 🇺🇸 Cincinnati, Ohio, United States

Braintree Research Site 213; 🇺🇸 Portland, Oregon, United States

Braintree Research Site 218; 🇺🇸 Flowood, Mississippi, United States

Braintree Research Site 204; 🇺🇸 Tucson, Arizona, United States

Braintree Research Site 222; 🇺🇸 Jacksonville, Florida, United States

Braintree Research Site 201; 🇺🇸 Palm Harbor, Florida, United States

Braintree Research Site 216; 🇺🇸 Columbia, South Carolina, United States

Braintree Research Site 217; 🇺🇸 Ogden, Utah, United States

Braintree Research Site 203; 🇺🇸 Jackson, Tennessee, United States

Braintree Research Site 208; 🇺🇸 Milwaukee, Wisconsin, United States

Braintree Research Site 221; 🇺🇸 Inverness, Florida, United States

Braintree Research Site 202; 🇺🇸 Franklin, Tennessee, United States