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

NCT00503607 | Completed Phase 3

• 1 other identifier: BLI-800-301
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 11

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.

Conditions

Colonoscopy

Keywords

colonoscopy; bowel preparation; prep

Outcome Measures

Primary Outcomes (1)

• Efficacy - preparation quality using a 4 point scale

  2-Day

Secondary Outcomes (1)

• Safety - preparation related side effects; laboratory analysis

  30-Day

Interventions

BLI-800 DRUG

Polyethylene glycol 3350 based bowel preparation DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Braintree Laboratories: lead

Study Sites (11)

Unknown Facility

Mobile, Alabama, 36693, United States

Location

Unknown Facility

Washington D.C., District of Columbia, 20010, United States

Location

Unknown Facility

Jupiter, Florida, 33458, United States

Location

Unknown Facility

Miami, Florida, 33143, United States

Location

Unknown Facility

New Smyrna Beach, Florida, 32168, United States

Location

Unknown Facility

Monroe, Louisiana, 71201, United States

Location

Unknown Facility

Laurel, Maryland, 20707, United States

Location

Unknown Facility

Great Neck, New York, 11023, United States

Location

Unknown Facility

Raleigh, North Carolina, 27612, United States

Location

Unknown Facility

Lancaster, Pennsylvania, 17604, United States

Location

Unknown Facility

Chesapeake, Virginia, 23320, United States

Location

Study Officials

• John D McGowan, BS

  Braintree Laboratories, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 17, 2007
• First Posted: July 19, 2007
• Study Start: July 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: December 27, 2007

Record last verified: 2007-12

Locations

US (11)