BLI801 Laxative in Constipated Adults

Constipation Clinical Trial

Official title:

A Pilot Efficacy Evaluation of BLI801 Laxative in Constipated Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01301781
• Other study ID #: BLI801-201
• Status: Completed
• Phase: Phase 2
• First received: February 22, 2011
• Last updated: September 27, 2012
• Start date: January 2011

Study information

• Verified date: September 2012
• Source: Braintree Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• BLI801
BLI801 laxative - oral solution
• Placebo
BLI801 placebo - oral solution

Locations

Country	Name	City	State
United States	Advanced Clinical Research Institute	Anaheim	California
United States	Long Island GI Research Group	Great Neck	New York
United States	Jupiter Research	Jupiter	Florida
United States	United Medical Research	New Smyrna Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Braintree Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of patients experiencing a bowel movement within 3 hours of the first study medication dose		3 hours	No
Secondary	percentage of patients experiencing a complete/satisfactory bowel movement (BM) within 3 hours of first dose		3 hours	No
Secondary	serum chemistry		7 days	Yes