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
52 participants
INTERVENTIONAL
2011-01-31
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
QUADRUPLE
Study Groups
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BLI801 laxative
BLI801 laxative - oral solution
BLI801
BLI801 laxative - oral solution
Placebo
BLI801 placebo - oral solution
Placebo
BLI801 placebo - oral solution
Interventions
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BLI801
BLI801 laxative - oral solution
Placebo
BLI801 placebo - oral solution
Eligibility Criteria
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Inclusion Criteria
* Subject has \< 3 satisfactory BMs during the run-in period
Exclusion Criteria
* Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments.
* Subjects who are allergic to any BLI801 component
* Subjects 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
18 Years
ALL
No
Sponsors
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Braintree Laboratories
INDUSTRY
Responsible Party
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Locations
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Advanced Clinical Research Institute
Anaheim, California, United States
Jupiter Research
Jupiter, Florida, United States
United Medical Research
New Smyrna Beach, Florida, United States
Long Island GI Research Group
Great Neck, New York, United States
Countries
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Other Identifiers
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BLI801-201
Identifier Type: -
Identifier Source: org_study_id