BLI-800-301: BLI-800 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy - Full Text View

Sponsored by:	Braintree Laboratories
Information provided by:	Braintree Laboratories
ClinicalTrials.gov Identifier:	NCT00503607

Purpose

This is a randomized, parallel, multi-center, single-blind study, comparing BLI-800 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy.

Condition	Intervention	Phase
Colonoscopy	Drug: BLI-800 Drug: Polyethylene glycol 3350 based bowel preparation	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind, Active Control, Parallel Assignment
Official Title:	A Safety and Efficacy Evaluation of BLI-800 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy

Further study details as provided by Braintree Laboratories:

Primary Outcome Measures:

Efficacy - preparation quality using a 4 point scale [ Time Frame: 2-Day ]

Secondary Outcome Measures:

Safety - preparation related side effects; laboratory analysis [ Time Frame: 30-Day ]

Estimated Enrollment:	400
Study Start Date:	July 2007
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication, including:
- Evaluation of BE results
- GI bleeding
- Anemia of unknown etiology
- Neoplastic disease surveillance
- Endosonography
- Inflammatory bowel disease
- Unknown diarrhea or constipation etiology
- Polypectomy
- Laser therapy
- Routine Screening
At least 18 years of age
Otherwise in good health, as determined by physical exam and medical history
If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, abstinent, or vasectomized spouse)
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 with impaired consciousness that predisposes them to pulmonary aspiration.
Subjects who are undergoing colonoscopy for foreign body removal and decompression.
Subjects with clinically significant electrolyte abnormalities based on Visit 1 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 history of renal or hepatic insufficiency or congestive heart failure.
Subjects who had previous gastrointestinal surgeries
Subjects who are pregnant or lactating, or intending to become pregnant during the study.
Subjects of childbearing potential who refuse a pregnancy test.
Subjects who are 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 clinical, surgical, drug, or device study within the past 30 days.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503607

Locations

United States, Alabama

Mobile, Alabama, United States, 36693
United States, District of Columbia

Washington, District of Columbia, United States, 20010
United States, Florida

New Smyrna Beach, Florida, United States, 32168

Miami, Florida, United States, 33143

Jupiter, Florida, United States, 33458
United States, Louisiana

Monroe, Louisiana, United States, 71201
United States, Maryland

Laurel, Maryland, United States, 20707
United States, New York

Great Neck, New York, United States, 11023
United States, North Carolina

Raleigh, North Carolina, United States, 27612
United States, Pennsylvania

Lancaster, Pennsylvania, United States, 17604
United States, Virginia

Chesapeake, Virginia, United States, 23320

Sponsors and Collaborators

Braintree Laboratories

Investigators

Study Director:

John D McGowan, BS

Braintree Laboratories, Inc.

More Information

Responsible Party:	Braintree Laboratories, Inc. ( John McGowan, Clinical Operations Manager )
Study ID Numbers:	BLI-800-301
Study First Received:	July 17, 2007
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00503607
Health Authority:	United States: Food and Drug Administration

Keywords provided by Braintree Laboratories:

colonoscopy
bowel preparation
prep

ClinicalTrials.gov processed this record on January 16, 2009