BLI850 vs an 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: NCT00756977
• 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
• Results First Submitted QC: 2013-07-08
• Status Verified: 2013-08
• Results First Posted: 2013-08-09
• Last Update Submitted: 2013-08-09
• Last Update Posted: 2013-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 394

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.

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-day	Percentage of patients with a successful preparation (cleaning rated as "Good" or "Excellent"

Secondary Outcome Measures

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

Trial Locations

Locations (12)

Miami Research Associates; 🇺🇸 Miami, Florida, United States

University of South Alabama; 🇺🇸 Mobile, Alabama, United States

Southeastern Clinical Research; 🇺🇸 Chattanooga, Tennessee, United States

Atlanta Gastroenterology Associates; 🇺🇸 Roswell, Georgia, United States

Jupiter Research; 🇺🇸 Jupiter, Florida, United States

United Medical Research; 🇺🇸 New Smyrna Beach, Florida, United States

Maryland Digestive Disease Research; 🇺🇸 Laurel, Maryland, United States

Delta Research Partners; 🇺🇸 Monroe, Louisiana, United States

Long Island GI Research Group; 🇺🇸 Great Neck, New York, United States

Carolina Digestive Health Associates; 🇺🇸 Harrisburg, North Carolina, United States

Wake Research Associates; 🇺🇸 Raleigh, North Carolina, United States

Regional Gastroenterology Associates of Lancaster; 🇺🇸 Lancaster, Pennsylvania, United States