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

This study has been completed.
Sponsor:
Information provided by:
Braintree Laboratories
ClinicalTrials.gov Identifier:
NCT00503607
First received: July 17, 2007
Last updated: December 20, 2007
Last verified: December 2007
  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 3

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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Jupiter, Florida, United States, 33458
Miami, Florida, United States, 33143
New Smyrna Beach, Florida, United States, 32168
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

No publications provided

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

Keywords provided by Braintree Laboratories:
colonoscopy
bowel preparation
prep

ClinicalTrials.gov processed this record on August 28, 2014