BLI801 Laxative in Constipated Adults

Phase 2

Completed

• Conditions: Constipation
• Interventions: Drug: BLI801; Drug: Placebo

• Registration Number: NCT01301781
• Lead Sponsor: Braintree Laboratories

Brief Summary

A pilot study to evaluate the safety and efficacy of BLI801 vs. placebo in constipated adults.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-22
• Study First Submitted QC: 2011-02-22
• Study First Posted: 2011-02-23
• Primary Completion: 2011-05
• Status Verified: 2012-09
• Disposition First Submitted: 2012-09-27
• Disposition First Submitted QC: 2012-09-27
• Last Update Submitted: 2012-09-27
• Disposition First Posted: 2012-10-01
• Last Update Posted: 2012-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Constipated, defined by ROME III definition
• Subject has < 3 satisfactory BMs during the run-in period

Exclusion Criteria

• Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon
• Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments.
• Subjects who are allergic to any BLI801 component
• Subjects taking narcotic analgesics or other medications known to cause constipation.
• Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures
• Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
• Subjects with an active history of drug or alcohol abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BLI801 laxative	BLI801	BLI801 laxative - oral solution
Placebo	Placebo	BLI801 placebo - oral solution

Primary Outcome Measures

Name	Time	Method
percentage of patients experiencing a bowel movement within 3 hours of the first study medication dose	3 hours

Secondary Outcome Measures

Name	Time	Method
percentage of patients experiencing a complete/satisfactory bowel movement (BM) within 3 hours of first dose	3 hours
serum chemistry	7 days

Trial Locations

Locations (4)

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

Jupiter Research; 🇺🇸 Jupiter, Florida, United States

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

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