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.

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Drug: BLI801; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Advanced Clinical Research Institute
  • Florida
    • Jupiter, Florida, United States, 33458
      • Jupiter Research
    • New Smyrna Beach, Florida, United States, 32168
      • United Medical Research
  • New York
    • Great Neck, New York, United States, 11023
      • Long Island GI Research Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BLI801 laxative; BLI801 laxative - oral solution	Drug: BLI801; BLI801 laxative - oral solution
Placebo Comparator: Placebo; BLI801 placebo - oral solution	Drug: Placebo; BLI801 placebo - oral solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
percentage of patients experiencing a bowel movement within 3 hours of the first study medication dose	3 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
percentage of patients experiencing a complete/satisfactory bowel movement (BM) within 3 hours of first dose	3 hours
serum chemistry	7 days

Collaborators and Investigators

• Sponsor: Braintree Laboratories

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: February 22, 2011
• First Submitted That Met QC Criteria: February 22, 2011
• First Posted (Estimate): February 23, 2011

Study Record Updates

• Last Update Posted (Estimate): October 1, 2012
• Last Update Submitted That Met QC Criteria: September 27, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: BLI801-201