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

NCT ID: NCT01786629

Last Updated: 2014-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 338 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31

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.

Conditions

Colonoscopy; Bowel Preparation; Endoscopy

Study Design

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

Study Groups

SUPREP Bowel Prep Kit

SUPREP Bowel Prep Kit

Group Type: EXPERIMENTAL

SUPREP Bowel Prep Kit

Intervention Type: DRUG

solution for oral administration prior to colonoscopy

FDA approved bowel preparation

FDA approved bowel preparation containing electrolytes

Group Type: ACTIVE_COMPARATOR

FDA approved bowel preparation containing electrolytes

Intervention Type: DRUG

solution for oral administration prior to colonoscopy

Interventions

SUPREP Bowel Prep Kit

solution for oral administration prior to colonoscopy

Intervention Type: DRUG

FDA approved bowel preparation containing electrolytes

solution for oral administration prior to colonoscopy

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 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

University of South Alabama

Mobile, Alabama, United States

Anaheim Clinical Trials

Anaheim, California, United States

Indiana University Medical Center

Indianapolis, Indiana, United States

Commonwealth Clinical Studies

Brockton, Massachusetts, United States

Gastrointestinal Associates

Jackson, Mississippi, United States

Long Island GI Research Group

Great Neck, New York, United States

Wake Research Associates

Raleigh, North Carolina, United States

Northwest Gastroenterology Clinic

Portland, Oregon, United States

Franklin Gastroenterology

Franklin, Tennessee, United States

Charlottesville Medical Research

Charlottesville, Virginia, United States

Countries

United States

References

Rex DK, DiPalma JA, McGowan J, Cleveland Mv. A comparison of oral sulfate solution with sodium picosulfate: magnesium citrate in split doses as bowel preparation for colonoscopy. Gastrointest Endosc. 2014 Dec;80(6):1113-23. doi: 10.1016/j.gie.2014.05.329. Epub 2014 Jul 12.

Reference Type: DERIVED

PMID: 25028274 (View on PubMed)

Other Identifiers

BLI800-480

Identifier Type: -

Identifier Source: org_study_id