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

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00756548
• Other study ID #: BLI850-302
• Secondary ID: BLI850-302
• Status: Completed
• Phase: Phase 3
• First received: September 18, 2008
• Last updated: December 3, 2013
• Start date: August 2008

Study information

• Verified date: December 2013
• Source: Braintree Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 386
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Colon Cancer

Intervention

Drug:
• BLI850
multi-dose preparation for oral administration prior to colonoscopy
• polyethylene glycol 3350 based bowel preparation
multi-dose preparation for oral administration prior to colonoscopy

Locations

Country	Name	City	State
United States	Advanced Clinical Research Institute	Anaheim	California
United States	Northwest Gastroenterology Associates	Bellevue	Washington
United States	Charlottesville Medical Research	Charlottesville	Virginia
United States	Franklin Gastroenterology	Franklin	Tennessee
United States	Memphis Gastroenterology Group	Germantown	Tennessee
United States	Houston Medical Research Associates	Houston	Texas
United States	Indiana University Medical Center	Indianapolis	Indiana
United States	Gastrointestinal Associates	Jackson	Mississippi
United States	The Frist Clinic	Nashville	Tennessee
United States	Advanced Clinical Research Institute	Orange	California
United States	Northwest Gastroenterology Clinic	Portland	Oregon
United States	Options Health Research	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Braintree Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy - Preparation Quality Using a 4 Point Scale	Percentage of patients with a successful preparation (cleaning rated as "Good" or "Excellent")	2 days	No
Secondary	Serum Chemistry Results (mEq/L)	Change from Baseline	2 days	Yes
Secondary	Hematology Results (%)	Change from Baseline	2 days	Yes
Secondary	Serum Chemistry Results (U/L)	Change from Baseline	2 days	Yes
Secondary	Serum Chemistry Results (mg/dL)	Change from Baseline	2 days	Yes
Secondary	Serum Chemistry Results (g/dL)	Change from Baseline	2 days	Yes
Secondary	Serum Chemistry Results - Glomerular Filtration Rate	Change from Baseline	2 days	Yes
Secondary	Hematology Results - Hemoglobin	Change from Baseline	2 days	Yes
Secondary	Hematology Results (1000/MCL)	Change from Baseline	2 days	Yes
Secondary	Hematology Results - Red Blood Cells	Change from Baseline	2 days	Yes
Secondary	Serum Chemistry Results (Osmolality)	Change from Baseline	2 days	Yes