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

A Safety and Efficacy Evaluation of BLI-800 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy

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

Study Overview

• Status: Completed
• Conditions: Colonoscopy
• Intervention / Treatment: Drug: BLI-800; Drug: Polyethylene glycol 3350 based bowel preparation

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36693
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
  • Florida
    • Jupiter, Florida, United States, 33458
    • Miami, Florida, United States, 33143
    • New Smyrna Beach, Florida, United States, 32168
  • Louisiana
    • Monroe, Louisiana, United States, 71201
  • Maryland
    • Laurel, Maryland, United States, 20707
  • New York
    • Great Neck, New York, United States, 11023
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17604
  • Virginia
    • Chesapeake, Virginia, United States, 23320

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy - preparation quality using a 4 point scale	2-Day

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety - preparation related side effects; laboratory analysis	30-Day

Collaborators and Investigators

• Sponsor: Braintree Laboratories
• Investigators: Study Director: John D McGowan, BS, Braintree Laboratories, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (ACTUAL): November 1, 2007
• Study Completion (ACTUAL): November 1, 2007

Study Registration Dates

• First Submitted: July 17, 2007
• First Submitted That Met QC Criteria: July 18, 2007
• First Posted (ESTIMATE): July 19, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): December 27, 2007
• Last Update Submitted That Met QC Criteria: December 20, 2007
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Keywords: colonoscopy; bowel preparation; prep
• Additional Relevant MeSH Terms: Gastrointestinal Agents; Laxatives; Polyethylene glycol 3350
• Other Study ID Numbers: BLI-800-301