BLI-800-302: 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): 360
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
    • Orange, California, United States, 92869
  • Mississippi
    • Jackson, Mississippi, United States, 39202
  • Oregon
    • Portland, Oregon, United States, 97210
  • Tennessee
    • Franklin, Tennessee, United States, 37067
    • Germantown, Tennessee, United States, 38138
    • Jackson, Tennessee, United States
    • Nashville, Tennessee, United States, 37203
  • Texas
    • Houston, Texas, United States, 77090
  • Washington
    • Bellevue, Washington, United States, 98004

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 Assignment
• 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, B.S., 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-800-302