A Safety and Efficacy Evaluation of BLI801 Laxative in Constipated Adults

Completed · Phase 2

Conditions studied: Constipation

In brief

A pilot study to evaluate the safety and efficacy of multiple BLI801 doses in constipated adults.

Key facts

Study ID

NCT01687985

Run by

Braintree Laboratories

People needed

81

Starts

2012-08-01

Expected to finish

2013-03-01

Last updated by the study team

2014-07-16

Who can join

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

You may qualify if…

• Male or female subjects at least 18 years of age
• Constipated, defined by ROME definition:
• Otherwise in good health, as determined by physical exam and medical history

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 currently 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

• Anaheim Clinical Trials — Anaheim, California, United States
• Commonwealth Clinical Studies — Brockton, Massachusetts, United States
• Clinsearch — Chattanooga, Tennessee, United States
• Memphis Gastroenterology — Germantown, Tennessee, United States

Full record on ClinicalTrials.gov

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