Clinical trial NCT00756548: BLI850-302: BLI850 vs an Approved Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy
Official title: BLI850-302: BLI850 vs an Approved 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: 386
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, intra-uterine device, 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 days
Secondary outcomes:
measure: Serum Chemistry Results (mEq/L)
timeFrame: 2 days
measure: Hematology Results (%)
timeFrame: 2 days
measure: Serum Chemistry Results (U/L)
timeFrame: 2 days
measure: Serum Chemistry Results (mg/dL)
timeFrame: 2 days
measure: Serum Chemistry Results (g/dL)
timeFrame: 2 days
measure: Serum Chemistry Results - Glomerular Filtration Rate
timeFrame: 2 days
measure: Hematology Results - Hemoglobin
timeFrame: 2 days
measure: Hematology Results (1000/MCL)
timeFrame: 2 days
measure: Hematology Results - Red Blood Cells
timeFrame: 2 days
measure: Serum Chemistry Results (Osmolality)
timeFrame: 2 days
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Orange
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Indianapolis
country: United States
facility: Indiana University Medical Center
state: Indiana
city: Jackson
country: United States
facility: Gastrointestinal Associates
state: Mississippi
city: Tulsa
country: United States
facility: Options Health Research
state: Oklahoma
city: Portland
country: United States
facility: Northwest Gastroenterology Clinic
state: Oregon
city: Franklin
country: United States
facility: Franklin Gastroenterology
state: Tennessee
city: Germantown
country: United States
facility: Memphis Gastroenterology Group
state: Tennessee
city: Nashville
country: United States
facility: The Frist Clinic
state: Tennessee
city: Houston
country: United States
facility: Houston Medical Research Associates
state: Texas
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Bellevue
country: United States
facility: Northwest Gastroenterology Associates
state: Washington
Study officials:
References: