A Safety and Efficacy Evaluation of BLI801 Laxative in Constipated Adults

Phase 2

Completed

• Conditions: Constipation
• Interventions: Drug: BLI801 laxative - low dose; Drug: BLI801 laxative - high dose

• Registration Number: NCT01687985
• Lead Sponsor: Braintree Laboratories

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-09-14
• Study First Submitted QC: 2012-09-14
• Study First Posted: 2012-09-19
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2014-07
• Disposition First Submitted: 2014-07-14
• Disposition First Submitted QC: 2014-07-14
• Last Update Submitted: 2014-07-14
• Disposition First Posted: 2014-07-16
• Last Update Posted: 2014-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BLI801 laxative - low dose	BLI801 laxative - low dose	BLI801 laxative - oral solution
BLI801 laxative - high dose	BLI801 laxative - high dose	BLI801 laxative - oral solution

Primary Outcome Measures

Name	Time	Method
Treatment Success	4 weeks	percent of patients experiencing a response in 3 out of 4 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
serum chemistry	4 weeks

Trial Locations

Locations (4)

Commonwealth Clinical Studies; 🇺🇸 Brockton, Massachusetts, United States

Memphis Gastroenterology; 🇺🇸 Germantown, Tennessee, United States

Anaheim Clinical Trials; 🇺🇸 Anaheim, California, United States

Clinsearch; 🇺🇸 Chattanooga, Tennessee, United States