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

NCT01786629 | Completed Phase 4 Results

• 1 other identifier: BLI800-480
• Study Type: interventional
• Target: 338
• Locations: 1 country
• Sites: 10

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With a Successful Preparation (Cleaning Rated as "Good" or "Excellent")

  Day of colonoscopy

Study Arms (2)

SUPREP Bowel Prep Kit

EXPERIMENTAL

SUPREP Bowel Prep Kit

Drug: SUPREP Bowel Prep Kit

FDA approved bowel preparation

ACTIVE COMPARATOR

FDA approved bowel preparation containing electrolytes

Drug: FDA approved bowel preparation containing electrolytes

Interventions

SUPREP Bowel Prep Kit DRUG

solution for oral administration prior to colonoscopy

SUPREP Bowel Prep Kit

FDA approved bowel preparation containing electrolytes DRUG

solution for oral administration prior to colonoscopy

FDA approved bowel preparation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Braintree Laboratories: lead

Study Sites (10)

University of South Alabama

Mobile, Alabama, 36693, United States

Location

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

Indiana University Medical Center

Indianapolis, Indiana, 46202, United States

Location

Commonwealth Clinical Studies

Brockton, Massachusetts, 02302, United States

Location

Gastrointestinal Associates

Jackson, Mississippi, 39202, United States

Location

Long Island GI Research Group

Great Neck, New York, 11023, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Northwest Gastroenterology Clinic

Portland, Oregon, 97210, United States

Location

Franklin Gastroenterology

Franklin, Tennessee, 37067, United States

Location

Charlottesville Medical Research

Charlottesville, Virginia, 22911, United States

Location

Related Publications (1)

• 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.

  PMID: 25028274 DERIVED

Results Point of Contact

• Title: John McGowan, Director Clinical Research
• Organization: Braintree Laboratories, Inc.

jmcgowan@braintreelabs.com

781-843-2202

Study Officials

• John McGowan, MPH

  Braintree Laboratories, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: February 8, 2013
• Study Start: December 1, 2012
• Primary Completion: May 1, 2013
• Last Updated: August 8, 2014
• Results First Posted: August 6, 2014

Record last verified: 2014-08

Locations

US (10)