Clinical trial NCT00756977: BLI850 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy
Official title: BLI850 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colon Cancer
Keywords: Colonoscopy
screening
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2008-09-22
Enrollment: 394
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, parallel, multi-center, single-blind study, comparing BLI850 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy.


Eligibility criteria: Inclusion Criteria:

1. Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication, including:

   * Evaluation of barium enema results
   * GI bleeding
   * Anemia of unknown etiology
   * Neoplastic disease surveillance
   * Abnormal Endosonography
   * Inflammatory bowel disease
   * Unknown diarrhea or constipation etiology
   * Polypectomy
   * Laser therapy
   * Routine screening
2. At least 18 years of age.
3. Otherwise in good health, as determined by physical exam and medical history.
4. 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).
5. Negative urine pregnancy test at screening, if applicable.
6. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study.

Exclusion Criteria:

1. Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or megacolon.
2. Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
3. Subjects who are undergoing colonoscopy for foreign body removal or decompression.
4. Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
5. Subjects who had previous significant gastrointestinal surgeries (e.g. colostomy, colectomy, gastric bypass).
6. Subjects who are pregnant or lactating, or intending to become pregnant during the study.
7. Subjects of childbearing potential who refuse a pregnancy test.
8. Subjects who are allergic to any preparation components
9. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
10. Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.

Primary outcomes:
measure: Efficacy - Preparation Quality Using a 4 Point Scale
timeFrame: 2-day
Secondary outcomes:
measure: Serum Chemistry Results (mg/dL)
timeFrame: 2 days
measure: Hematology Results (%)
timeFrame: 2 days
measure: Serum Chemistry Results (U/L)
timeFrame: 2 days
measure: Serum Chemistry Results (mEq/L)
timeFrame: 2 days
measure: Serum Chemistry Results (g/dL)
timeFrame: 2 days
measure: Serum Chemistry Results (GFR)
timeFrame: 2 days
measure: Hematology Results (1000/MCL)
timeFrame: 2 days
measure: Hematology Results - Hemoglobin
timeFrame: 2 days
measure: Hematology Results - Red Blood Cells
timeFrame: 2 days
measure: Serum Chemistry Results (Osmolality)
timeFrame: 2 days
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: Jupiter
country: United States
facility: Jupiter Research
state: Florida
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: New Smyrna Beach
country: United States
facility: United Medical Research
state: Florida
city: Roswell
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Monroe
country: United States
facility: Delta Research Partners
state: Louisiana
city: Laurel
country: United States
facility: Maryland Digestive Disease Research
state: Maryland
city: Great Neck
country: United States
facility: Long Island GI Research Group
state: New York
city: Harrisburg
country: United States
facility: Carolina Digestive Health Associates
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Lancaster
country: United States
facility: Regional Gastroenterology Associates of Lancaster
state: Pennsylvania
city: Chattanooga
country: United States
facility: Southeastern Clinical Research
state: Tennessee
Study officials:
affiliation: Braintree Laboratories
name: John D McGowan
role: STUDY_DIRECTOR
References: