BLI801 Laxative in Constipated Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Braintree Laboratories
ClinicalTrials.gov Identifier:
NCT01301781
First received: February 22, 2011
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

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


Condition Intervention Phase
Constipation
Drug: BLI801
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Efficacy Evaluation of BLI801 Laxative in Constipated Adults

Resource links provided by NLM:


Further study details as provided by Braintree Laboratories:

Primary Outcome Measures:
  • percentage of patients experiencing a bowel movement within 3 hours of the first study medication dose [ Time Frame: 3 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • percentage of patients experiencing a complete/satisfactory bowel movement (BM) within 3 hours of first dose [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
  • serum chemistry [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Enrollment: 52
Study Start Date: January 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01301781

Locations
United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
United States, Florida
Jupiter Research
Jupiter, Florida, United States, 33458
United Medical Research
New Smyrna Beach, Florida, United States, 32168
United States, New York
Long Island GI Research Group
Great Neck, New York, United States, 11023
Sponsors and Collaborators
Braintree Laboratories
  More Information

No publications provided

Responsible Party: Braintree Laboratories
ClinicalTrials.gov Identifier: NCT01301781     History of Changes
Other Study ID Numbers: BLI801-201
Study First Received: February 22, 2011
Last Updated: September 27, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Laxatives
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014