Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Pilot Efficacy Evaluation of BLI-801 as a Laxative in Constipated Adults

This study has been completed.
Information provided by:
Braintree Laboratories Identifier:
First received: December 20, 2007
Last updated: September 24, 2009
Last verified: September 2009

December 20, 2007
September 24, 2009
October 2007
January 2008   (final data collection date for primary outcome measure)
Bowel Movement Count [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00583154 on Archive Site
Adverse events [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
A Pilot Efficacy Evaluation of BLI-801 as a Laxative in Constipated Adults
A Pilot Efficacy Evaluation of BLI-801 as a Laxative in Constipated Adults

To compare the safety and efficacy of BLI-801 administered at 4 dose levels in constipated adults.

Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Drug: BLI-801
    Dose 1
  • Drug: BLI-801
    Dose 2
  • Drug: BLI-801
    Dose 3
  • Drug: BLI-801
    Dose 4
  • Experimental: 1
    BLI-801 Dose 1
    Intervention: Drug: BLI-801
  • Experimental: 2
    BLI-801 Dose 2
    Intervention: Drug: BLI-801
  • Experimental: 3
    BLI-801 Dose 3
    Intervention: Drug: BLI-801
  • Experimental: 4
    BLI-801 Dose 4
    Intervention: Drug: BLI-801
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subjects at least 18 years of age
  • Constipated according to ROME I criteria
  • Otherwise in good health, as determined by physical exam and medical history
  • If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse)
  • Negative urine pregnancy test at screening, if applicable
  • In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

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 for the duration of the study
  • Subjects who are pregnant or lactating, or intending to become pregnant during the study
  • Subjects of childbearing potential who refuse a pregnancy test
  • Subjects who are allergic to any BLI-801 component.
  • 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
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
John McGowan, Clinical Operations Manager, Braintree Laboratories, Inc.
Braintree Laboratories
Not Provided
Study Director: John McGowan Braintree Laboratories, Inc.
Braintree Laboratories
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP