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

Phase 3

Completed

• Conditions: Colon Cancer
• Interventions: Drug: BLI850; Drug: polyethylene glycol 3350 based bowel preparation

• Registration Number: NCT00756548
• Lead Sponsor: Braintree Laboratories

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-09-18
• Study First Submitted QC: 2008-09-19
• Study First Posted: 2008-09-22
• Primary Completion: 2008-11
• Disposition First Submitted: 2009-11-16
• Disposition First Submitted QC: 2009-11-16
• Disposition First Posted: 2009-11-18
• Results First Submitted: 2013-02-19
• Status Verified: 2013-12
• Results First Submitted QC: 2013-12-03
• Last Update Submitted: 2013-12-03
• Results First Posted: 2013-12-27
• Last Update Posted: 2013-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 386

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	BLI850	multi-dose preparation for oral administration prior to colonoscopy
2	polyethylene glycol 3350 based bowel preparation	multi-dose preparation for oral administration prior to colonoscopy

Primary Outcome Measures

Name	Time	Method
Efficacy - Preparation Quality Using a 4 Point Scale	2 days	Percentage of patients with a successful preparation (cleaning rated as "Good" or "Excellent")

Secondary Outcome Measures

Name	Time	Method
Hematology Results - Red Blood Cells	2 days	Change from Baseline
Serum Chemistry Results (Osmolality)	2 days	Change from Baseline
Hematology Results - Hemoglobin	2 days	Change from Baseline
Hematology Results (1000/MCL)	2 days	Change from Baseline
Serum Chemistry Results (mEq/L)	2 days	Change from Baseline
Hematology Results (%)	2 days	Change from Baseline
Serum Chemistry Results (U/L)	2 days	Change from Baseline
Serum Chemistry Results (mg/dL)	2 days	Change from Baseline
Serum Chemistry Results (g/dL)	2 days	Change from Baseline
Serum Chemistry Results - Glomerular Filtration Rate	2 days	Change from Baseline

Trial Locations

Locations (11)

Franklin Gastroenterology; 🇺🇸 Franklin, Tennessee, United States

Gastrointestinal Associates; 🇺🇸 Jackson, Mississippi, United States

Advanced Clinical Research Institute; 🇺🇸 Orange, California, United States

Memphis Gastroenterology Group; 🇺🇸 Germantown, Tennessee, United States

Houston Medical Research Associates; 🇺🇸 Houston, Texas, United States

The Frist Clinic; 🇺🇸 Nashville, Tennessee, United States

Options Health Research; 🇺🇸 Tulsa, Oklahoma, United States

Indiana University Medical Center; 🇺🇸 Indianapolis, Indiana, United States

Northwest Gastroenterology Associates; 🇺🇸 Bellevue, Washington, United States

Charlottesville Medical Research; 🇺🇸 Charlottesville, Virginia, United States

Northwest Gastroenterology Clinic; 🇺🇸 Portland, Oregon, United States