BLI801 Laxative in Constipated Adults

Completed · Phase 2 · Has a placebo group

Conditions studied: Constipation

In brief

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

Key facts

Study ID

NCT01301781

Run by

Braintree Laboratories

People needed

52

Starts

2011-01-01

Last updated by the study team

2012-10-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Advanced Clinical Research Institute — Anaheim, California, United States
• Jupiter Research — Jupiter, Florida, United States
• United Medical Research — New Smyrna Beach, Florida, United States
• Long Island GI Research Group — Great Neck, New York, United States

Full record on ClinicalTrials.gov

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