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A Safety and Efficacy Evaluation of BLI801 Laxative in Constipated Adults

Sponsor
Braintree Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT01687985
Collaborator
(none)
81
Enrollment
4
Locations
2
Arms
7
Duration (Months)
20.3
Patients Per Site
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: BLI801 laxative - low dose
  • Drug: BLI801 laxative - high dose
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
81 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Safety and Efficacy Evaluation of BLI801 Laxative in Constipated Adults
Study Start Date :
Aug 1, 2012
Actual Primary Completion Date :
Mar 1, 2013
Actual Study Completion Date :
Mar 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • BLI801

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Treatment Success [4 weeks]

      percent of patients experiencing a response in 3 out of 4 weeks of treatment

    Secondary Outcome Measures

    1. serum chemistry [4 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Anaheim Clinical Trials Anaheim California United States 92801
    2 Commonwealth Clinical Studies Brockton Massachusetts United States 02302
    3 Clinsearch Chattanooga Tennessee United States 37421
    4 Memphis Gastroenterology Germantown Tennessee United States 38138

    Sponsors and Collaborators

    • Braintree Laboratories

    Investigators

    • Study Director: John McGowan, MPH, Braintree Laboratories, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Braintree Laboratories
    ClinicalTrials.gov Identifier:
    NCT01687985
    Other Study ID Numbers:
    • BLI801-202
    First Posted:
    Sep 19, 2012
    Last Update Posted:
    Jul 16, 2014
    Last Verified:
    Jul 1, 2014
    Additional relevant MeSH terms:
    Constipation
    Laxatives
    Cathartics

    Study Results

    No Results Posted as of Jul 16, 2014