BLI-800-302: BLI-800 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00503815
Recruitment Status : Completed
First Posted : July 19, 2007
Last Update Posted : December 27, 2007
Information provided by:
Braintree Laboratories

Brief Summary:
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 or disease Intervention/treatment Phase
Colonoscopy Drug: BLI-800 Drug: Polyethylene glycol 3350 based bowel preparation Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Official Title: A Safety and Efficacy Evaluation of BLI-800 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy
Study Start Date : July 2007
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Primary Outcome Measures :
  1. Efficacy - preparation quality using a 4 point scale [ Time Frame: 2-Day ]

Secondary Outcome Measures :
  1. Safety-preparation related side effects; laboratory analysis [ Time Frame: 30-Day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00503815

United States, California
Anaheim, California, United States, 92801
Orange, California, United States, 92869
United States, Mississippi
Jackson, Mississippi, United States, 39202
United States, Oregon
Portland, Oregon, United States, 97210
United States, Tennessee
Franklin, Tennessee, United States, 37067
Germantown, Tennessee, United States, 38138
Jackson, Tennessee, United States
Nashville, Tennessee, United States, 37203
United States, Texas
Houston, Texas, United States, 77090
United States, Washington
Bellevue, Washington, United States, 98004
Sponsors and Collaborators
Braintree Laboratories
Study Director: John D McGowan, B.S. Braintree Laboratories, Inc.

Responsible Party: John McGowan, Clinical Operations Manager, Braintree Laboratories, Inc. Identifier: NCT00503815     History of Changes
Other Study ID Numbers: BLI-800-302
First Posted: July 19, 2007    Key Record Dates
Last Update Posted: December 27, 2007
Last Verified: December 2007

Keywords provided by Braintree Laboratories:
bowel preparation

Additional relevant MeSH terms:
Polyethylene glycol 3350
Gastrointestinal Agents