BLI800-480: A Safety and Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

Phase 4

Completed

• Conditions: Bowel Preparation; Colonoscopy; Endoscopy
• Interventions: Drug: SUPREP Bowel Prep Kit; Drug: FDA approved bowel preparation containing electrolytes

• Registration Number: NCT01786629
• Lead Sponsor: Braintree Laboratories

Brief Summary

To compare the safety, tolerance and efficacy of SUPREP Bowel Prep Kit to an FDA approved control as bowel preparations prior to colonoscopy in adult patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-02-06
• Study First Submitted QC: 2013-02-07
• Study First Posted: 2013-02-08
• Primary Completion: 2013-05
• Results First Submitted: 2014-07-14
• Results First Submitted QC: 2014-07-14
• Status Verified: 2014-08
• Results First Posted: 2014-08-06
• Last Update Submitted: 2014-08-06
• Last Update Posted: 2014-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 338

Inclusion Criteria

Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.

At least 18 years of age

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

Exclusion Criteria

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 screening laboratory results, such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.

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.

Subjects who withdraw consent before completion of Visit 1 procedures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SUPREP Bowel Prep Kit	SUPREP Bowel Prep Kit	SUPREP Bowel Prep Kit
FDA approved bowel preparation	FDA approved bowel preparation containing electrolytes	FDA approved bowel preparation containing electrolytes

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With a Successful Preparation (Cleaning Rated as "Good" or "Excellent")	Day of colonoscopy

Trial Locations

Locations (10)

Gastrointestinal Associates; 🇺🇸 Jackson, Mississippi, United States

Wake Research Associates; 🇺🇸 Raleigh, North Carolina, United States

University of South Alabama; 🇺🇸 Mobile, Alabama, United States

Indiana University Medical Center; 🇺🇸 Indianapolis, Indiana, United States

Charlottesville Medical Research; 🇺🇸 Charlottesville, Virginia, United States

Franklin Gastroenterology; 🇺🇸 Franklin, Tennessee, United States

Northwest Gastroenterology Clinic; 🇺🇸 Portland, Oregon, United States

Long Island GI Research Group; 🇺🇸 Great Neck, New York, United States

Anaheim Clinical Trials; 🇺🇸 Anaheim, California, United States

Commonwealth Clinical Studies; 🇺🇸 Brockton, Massachusetts, United States