Know Cancer

forgot password

BLI850 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy

Phase 3
18 Years
Not Enrolling
Colon Cancer

Thank you

Trial Information

BLI850 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy

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

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Efficacy - preparation quality using a 4 point scale

Outcome Time Frame:


Safety Issue:


Principal Investigator

John D McGowan

Investigator Role:

Study Director

Investigator Affiliation:

Braintree Laboratories


United States: Food and Drug Administration

Study ID:




Start Date:

August 2008

Completion Date:

Related Keywords:

  • Colon Cancer
  • Colonoscopy
  • screening
  • Colonic Neoplasms



Long Island GI Research Group Great Neck, New York  11023
Regional Gastroenterology Associates of Lancaster Lancaster, Pennsylvania  17604
Atlanta Gastroenterology Associates Atlanta, Georgia  
University of South Alabama Mobile, Alabama  36693
Wake Research Associates Raleigh, North Carolina  27612
Miami Research Associates Miami, Florida  33173
Maryland Digestive Disease Research Laurel, Maryland  20707
Southeastern Clinical Research Chattanooga, Tennessee  37403
Jupiter Research Jupiter, Florida  33458
United Medical Research New Smyrna Beach, Florida  32168
Delta Research Partners Monroe, Louisiana  71201
Carolina Digestive Health Associates Harrisburg, North Carolina  28075