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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00583154
First Posted: December 31, 2007
Last Update Posted: September 28, 2009
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:
Braintree Laboratories
December 20, 2007
December 31, 2007
September 28, 2009
October 2007
January 2008   (Final data collection date for primary outcome measure)
Bowel Movement Count [ Time Frame: 24 hours ]
Same as current
Complete list of historical versions of study NCT00583154 on ClinicalTrials.gov Archive Site
Adverse events [ Time Frame: 24 hours ]
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
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Constipation
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00583154
BLI-801-101
No
Not Provided
Not Provided
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