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


Phase 3
18 Years
N/A
Not Enrolling
Both
Colon Cancer

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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
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.

Type of Study:

Interventional

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:

2-day

Safety Issue:

No

Principal Investigator

John D McGowan

Investigator Role:

Study Director

Investigator Affiliation:

Braintree Laboratories

Authority:

United States: Food and Drug Administration

Study ID:

BLI850-301

NCT ID:

NCT00756977

Start Date:

August 2008

Completion Date:

Related Keywords:

  • Colon Cancer
  • Colonoscopy
  • screening
  • Colonic Neoplasms

Name

Location

Long Island GI Research GroupGreat Neck, New York  11023
Regional Gastroenterology Associates of LancasterLancaster, Pennsylvania  17604
Atlanta Gastroenterology AssociatesAtlanta, Georgia  
University of South AlabamaMobile, Alabama  36693
Wake Research AssociatesRaleigh, North Carolina  27612
Miami Research AssociatesMiami, Florida  33173
Maryland Digestive Disease ResearchLaurel, Maryland  20707
Southeastern Clinical ResearchChattanooga, Tennessee  37403
Jupiter ResearchJupiter, Florida  33458
United Medical ResearchNew Smyrna Beach, Florida  32168
Delta Research PartnersMonroe, Louisiana  71201
Carolina Digestive Health AssociatesHarrisburg, North Carolina  28075