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

Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00503607
• Other study ID #: BLI-800-301
• Status: Completed
• Phase: Phase 3
• First received: July 17, 2007
• Last updated: December 20, 2007
• Start date: July 2007
• Est. completion date: November 2007

Study information

• Verified date: December 2007
• Source: Braintree Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• BLI-800

• Polyethylene glycol 3350 based bowel preparation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Braintree Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy - preparation quality using a 4 point scale		2-Day
Secondary	Safety - preparation related side effects; laboratory analysis		30-Day