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BLI850-302: BLI850 vs an Approved Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy


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

Thank you

Trial Information

BLI850-302: BLI850 vs an Approved 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

Authority:

United States: Food and Drug Administration

Study ID:

BLI850-302

NCT ID:

NCT00756548

Start Date:

August 2008

Completion Date:

Related Keywords:

  • Colon Cancer
  • colonoscopy
  • screening
  • Colonic Neoplasms

Name

Location

Advanced Clinical Research InstituteAnaheim, California  92801
Northwest Gastroenterology AssociatesBellevue, Washington  98004
Indiana University Medical CenterIndianapolis, Indiana  46202
Memphis Gastroenterology GroupGermantown, Tennessee  38138
Options Health ResearchTulsa, Oklahoma  74104
Northwest Gastroenterology ClinicPortland, Oregon  97210
Gastrointestinal AssociatesJackson, Mississippi  39202
Franklin GastroenterologyFranklin, Tennessee  37067
The Frist ClinicNashville, Tennessee  37203
Houston Medical Research AssociatesHouston, Texas  77090
Charlottesville Medical ResearchCharlottesville, Virginia  22911