A Pilot Efficacy Evaluation of BLI-801 as a Laxative in Constipated Adults
NCT ID: NCT00583154
Last Updated: 2009-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2007-10-31
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
BLI-801 Dose 1
BLI-801
Dose 1
2
BLI-801 Dose 2
BLI-801
Dose 2
3
BLI-801 Dose 3
BLI-801
Dose 3
4
BLI-801 Dose 4
BLI-801
Dose 4
Interventions
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BLI-801
Dose 1
BLI-801
Dose 2
BLI-801
Dose 3
BLI-801
Dose 4
Eligibility Criteria
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Inclusion Criteria
* 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 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
ALL
No
Sponsors
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Braintree Laboratories
INDUSTRY
Responsible Party
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Braintree Laboratories, Inc.
Principal Investigators
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John McGowan
Role: STUDY_DIRECTOR
Braintree Laboratories, Inc.
Locations
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Anaheim, California, United States
Cranston, Rhode Island, United States
Cumberland, Rhode Island, United States
Countries
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Other Identifiers
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BLI-801-101
Identifier Type: -
Identifier Source: org_study_id
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