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BLI850 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy | Clinical Trials | Clareo Health

COMPLETEDPHASE3

BLI850 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy

NCT00756977•Braintree Laboratories

View on ClinicalTrials.gov

Summary

This is a randomized, parallel, multi-center, single-blind study, comparing BLI850 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication, including:
•* Evaluation of barium enema results
•* GI bleeding
•* Anemia of unknown etiology
•* Neoplastic disease surveillance
•* Abnormal Endosonography
•* Inflammatory bowel disease
•* Unknown diarrhea or constipation etiology
•* Polypectomy
•* Laser therapy
+6 more criteria

Exclusion Criteria

•1. Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or megacolon.
•2. Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
•3. Subjects who are undergoing colonoscopy for foreign body removal or decompression.
•4. Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
•5. Subjects who had previous significant gastrointestinal surgeries (e.g. colostomy, colectomy, gastric bypass).
•6. Subjects who are pregnant or lactating, or intending to become pregnant during the study.
•7. Subjects of childbearing potential who refuse a pregnancy test.
•8. Subjects who are allergic to any preparation components
•9. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
•10. Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.

Locations (12)

University of South Alabama

Mobile, Alabama, United States

Jupiter Research

Jupiter, Florida, United States

Miami Research Associates

Miami, Florida, United States

United Medical Research

New Smyrna Beach, Florida, United States

Atlanta Gastroenterology Associates

Roswell, Georgia, United States

Delta Research Partners

Monroe, Louisiana, United States

Maryland Digestive Disease Research

Laurel, Maryland, United States

Long Island GI Research Group

Great Neck, New York, United States

Carolina Digestive Health Associates

Harrisburg, North Carolina, United States

Wake Research Associates

Raleigh, North Carolina, United States

Key Dates

Start Date

August 1, 2008

Primary Completion Date

November 1, 2008

Last Updated

August 15, 2013

Enrollment

394

ACTUAL participants

Conditions

Colon Cancer

Interventions

BLI850

DRUG

polyethylene glycol 3350 based bowel preparation

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 15, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

BLI850 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy

Inclusion Criteria

Exclusion Criteria

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