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

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.
ClinicalTrials.gov Identifier: NCT00583154
Recruitment Status : Completed
First Posted : December 31, 2007
Last Update Posted : September 28, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
To compare the safety and efficacy of BLI-801 administered at 4 dose levels in constipated adults.

Condition or disease Intervention/treatment Phase
Constipation Drug: BLI-801 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Efficacy Evaluation of BLI-801 as a Laxative in Constipated Adults
Study Start Date : October 2007
Primary Completion Date : January 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
BLI-801 Dose 1
Drug: BLI-801
Dose 1
Experimental: 2
BLI-801 Dose 2
Drug: BLI-801
Dose 2
Experimental: 3
BLI-801 Dose 3
Drug: BLI-801
Dose 3
Experimental: 4
BLI-801 Dose 4
Drug: BLI-801
Dose 4


Outcome Measures

Primary Outcome Measures :
  1. Bowel Movement Count [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 24 hours ]

Eligibility Criteria

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:

  • 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
Contacts and Locations

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): NCT00583154


Locations
United States, California
Anaheim, California, United States
United States, Rhode Island
Cranston, Rhode Island, United States
Cumberland, Rhode Island, United States
Sponsors and Collaborators
Braintree Laboratories
Investigators
Study Director: John McGowan Braintree Laboratories, Inc.
More Information

Responsible Party: John McGowan, Clinical Operations Manager, Braintree Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00583154     History of Changes
Other Study ID Numbers: BLI-801-101
First Posted: December 31, 2007    Key Record Dates
Last Update Posted: September 28, 2009
Last Verified: September 2009

Keywords provided by Braintree Laboratories:
constipation
laxative

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Laxatives
Cathartics
Gastrointestinal Agents