A Safety and Efficacy Evaluation of BLI801 Laxative in Constipated Adults
NCT ID: NCT01687985
Last Updated: 2014-07-16
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
81 participants
INTERVENTIONAL
2012-08-31
2013-03-31
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
DOUBLE
Study Groups
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BLI801 laxative - low dose
BLI801 laxative - oral solution
BLI801 laxative - low dose
BLI801 laxative - oral solution
BLI801 laxative - high dose
BLI801 laxative - oral solution
BLI801 laxative - high dose
BLI801 laxative - oral solution
Interventions
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BLI801 laxative - low dose
BLI801 laxative - oral solution
BLI801 laxative - high dose
BLI801 laxative - oral solution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Constipated, defined by ROME definition:
Otherwise in good health, as determined by physical exam and medical history
Exclusion Criteria
Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments
Subjects who are allergic to any BLI801 component
Subjects currently 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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Principal Investigators
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John McGowan, MPH
Role: STUDY_DIRECTOR
Braintree Laboratories, Inc.
Locations
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Anaheim Clinical Trials
Anaheim, California, United States
Commonwealth Clinical Studies
Brockton, Massachusetts, United States
Clinsearch
Chattanooga, Tennessee, United States
Memphis Gastroenterology
Germantown, Tennessee, United States
Countries
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Other Identifiers
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BLI801-202
Identifier Type: -
Identifier Source: org_study_id
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