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BLI801 Laxative in Constipated Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01301781
First Posted: February 23, 2011
Last Update Posted: October 1, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Braintree Laboratories
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • percentage of patients experiencing a complete/satisfactory bowel movement (BM) within 3 hours of first dose [ Time Frame: 3 hours ]
  • serum chemistry [ Time Frame: 7 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Braintree Laboratories
ClinicalTrials.gov Identifier: NCT01301781     History of Changes
Other Study ID Numbers: BLI801-201
First Submitted: February 22, 2011
First Posted: February 23, 2011
Last Update Posted: October 1, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Pharmaceutical Solutions
Laxatives
Cathartics
Gastrointestinal Agents