BLI801 Laxative in Constipated Adults

A Pilot Efficacy Evaluation of BLI801 Laxative in Constipated Adults

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

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