BLI801 Laxative in Constipated Adults

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

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

Criteria

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