A Safety and Efficacy Evaluation of BLI801 Laxative in Constipated Adults

Braintree Laboratories

Status and phase: Completed; Phase 2

Conditions: Constipation

Treatments: Drug: BLI801 laxative - high dose; Drug: BLI801 laxative - low dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01687985

BLI801-202

Details and patient eligibility

About

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

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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81 participants in 2 patient groups

BLI801 laxative - low dose

Experimental group

Description:

BLI801 laxative - oral solution

Treatment:

Drug: BLI801 laxative - low dose

BLI801 laxative - high dose

Experimental group

Description:

BLI801 laxative - oral solution

Treatment:

Drug: BLI801 laxative - high dose