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

NCT ID: NCT03404401

Last Updated: 2021-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 620 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-11
• Study Completion Date: 2018-07-10

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.

Conditions

Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BLI4700 Bowel Preparation

Group Type: EXPERIMENTAL

BLI4700

Intervention Type: DRUG

Oral bowel preparation

FDA Approved Bowel Preparation

Group Type: ACTIVE_COMPARATOR

Polyethylene glycol bowel preparation

Intervention Type: DRUG

Oral bowel preparation

Interventions

BLI4700

Oral bowel preparation

Intervention Type: DRUG

Polyethylene glycol bowel preparation

Oral bowel preparation

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Braintree Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John McGowan, MPH

Role: STUDY_DIRECTOR

Braintree Laboratories, Inc.

Locations

Braintree Research Site 212

Mobile, Alabama, United States

Braintree Research Site 204

Tucson, Arizona, United States

Braintree Research Site 209

Anaheim, California, United States

Braintree Research Site 219

Chula Vista, California, United States

Braintree Research Site 206

Los Angeles, California, United States

Braintree Research Site 220

San Diego, California, United States

Braintree Research Site 221

Inverness, Florida, United States

Braintree Research Site 222

Jacksonville, Florida, United States

Braintree Research Site 201

Palm Harbor, Florida, United States

Braintree Research Site 224

Atlanta, Georgia, United States

Braintree Research Site 215

Decatur, Georgia, United States

Braintree Research Site 223

Lake Charles, Louisiana, United States

Braintree Research Site 211

Monroe, Louisiana, United States

Braintree Research Site 207

Hagerstown, Maryland, United States

Braintree Research Site 218

Flowood, Mississippi, United States

Braintree Research Site 210

Great Neck, New York, United States

Braintree Research Site 214

Cincinnati, Ohio, United States

Braintree Research Site 213

Portland, Oregon, United States

Braintree Research Site 216

Columbia, South Carolina, United States

Braintree Research Site 202

Franklin, Tennessee, United States

Braintree Research Site 203

Jackson, Tennessee, United States

Braintree Research Site 217

Ogden, Utah, United States

Braintree Research Site 208

Milwaukee, Wisconsin, United States

Countries

United States

References

Di Palma JA, Bhandari R, Cleveland MV, Mishkin DS, Tesoriero J, Hall S, McGowan J. A Safety and Efficacy Comparison of a New Sulfate-Based Tablet Bowel Preparation Versus a PEG and Ascorbate Comparator in Adult Subjects Undergoing Colonoscopy. Am J Gastroenterol. 2021 Feb 1;116(2):319-328. doi: 10.14309/ajg.0000000000001020.

Reference Type: DERIVED

PMID: 33165006 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

BLI4700-301

Identifier Type: -

Identifier Source: org_study_id