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

Phase 3

Completed

• Conditions: Colonoscopy

• Registration Number: NCT00503607
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-17
• Study First Submitted QC: 2007-07-18
• Study First Posted: 2007-07-19
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-20
• Last Update Posted: 2007-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy - preparation quality using a 4 point scale	2-Day

Secondary Outcome Measures

Name	Time	Method
Safety - preparation related side effects; laboratory analysis	30-Day