BLI801 Laxative in Constipated Adults

Braintree Laboratories

Status and phase: Completed; Phase 2

Conditions: Constipation

Treatments: Drug: BLI801; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01301781

BLI801-201

Details and patient eligibility

About

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

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups, including a placebo group

BLI801 laxative

Experimental group

Description:

BLI801 laxative - oral solution

Treatment:

Drug: BLI801

Placebo

Placebo Comparator group

Description:

BLI801 placebo - oral solution

Treatment:

Drug: Placebo