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A Safety and Efficacy Evaluation of BLI801 Laxative in Constipated Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Braintree Laboratories
ClinicalTrials.gov Identifier:
NCT01687985
First received: September 14, 2012
Last updated: May 2, 2013
Last verified: May 2013
History of Changes
  Purpose

A pilot study to evaluate the safety and efficacy of multiple BLI801 doses in constipated adults.


Condition Intervention Phase
Constipation
 Drug: BLI801 laxative - low dose
Drug: BLI801 laxative - high dose
 Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Constipation
U.S. FDA Resources

Further study details as provided by Braintree Laboratories:

Primary Outcome Measures:
  • Treatment Success [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    percent of patients experiencing a response in 3 out of 4 weeks of treatment


Secondary Outcome Measures:
  • serum chemistry [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: August 2012
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BLI801 laxative - low dose
BLI801 laxative - oral solution
 Drug: BLI801 laxative - low dose
BLI801 laxative - oral solution
Experimental: BLI801 laxative - high dose
BLI801 laxative - oral solution
 Drug: BLI801 laxative - high dose
BLI801 laxative - oral solution
Other Name: BLI801

  Eligibility

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

Inclusion Criteria:

Male or female subjects at least 18 years of age

Constipated, defined by ROME definition:

Otherwise in good health, as determined by physical exam and medical history

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 currently 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687985

Locations
United States, California
Anaheim Clinical Trials
Anaheim, California, United States, 92801
United States, Massachusetts
Commonwealth Clinical Studies
Brockton, Massachusetts, United States, 02302
United States, Tennessee
Clinsearch
Chattanooga, Tennessee, United States, 37421
Memphis Gastroenterology
Germantown, Tennessee, United States, 38138
Sponsors and Collaborators
Braintree Laboratories
Investigators
Study Director: John McGowan, MPH Braintree Laboratories, Inc.
  More Information

No publications provided

Responsible Party: Braintree Laboratories
ClinicalTrials.gov Identifier: NCT01687985     History of Changes
Other Study ID Numbers: BLI801-202
Study First Received: September 14, 2012
Last Updated: May 2, 2013
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 May 21, 2013