A Safety and Efficacy Evaluation of BLI801 Laxative in Constipated Adults

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Braintree Laboratories
• Treatments: Cathartics; Laxatives; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

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

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 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