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BLI801 Laxative in Constipated Adults

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ClinicalTrials.gov Identifier: NCT01301781
Recruitment Status : Completed
First Posted : February 23, 2011
Last Update Posted : October 1, 2012
Sponsor:
Information provided by (Responsible Party):
Braintree Laboratories

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

Condition or disease Intervention/treatment Phase
Constipation Drug: BLI801 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
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
Study Start Date : January 2011
Actual Primary Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

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



Primary Outcome Measures :
  1. percentage of patients experiencing a bowel movement within 3 hours of the first study medication dose [ Time Frame: 3 hours ]

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


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

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

Responsible Party: Braintree Laboratories
ClinicalTrials.gov Identifier: NCT01301781     History of Changes
Other Study ID Numbers: BLI801-201
First Posted: February 23, 2011    Key Record Dates
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