Pharmacodynamic, Pharmacokinetic, and Tolerability Study of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation
NCT ID: NCT01993875
Last Updated: 2019-12-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
164 participants
INTERVENTIONAL
2013-10-31
2014-01-31
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
TRIPLE
Study Groups
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Lubiprostone
Lubiprostone
Liquid formulation, 12 mcg x 2 pumps administered orally twice daily (BID)
Placebo
Placebo
Matching liquid placebo, 0 mcg x 2 pumps administered orally twice daily (BID)
Interventions
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Lubiprostone
Liquid formulation, 12 mcg x 2 pumps administered orally twice daily (BID)
Placebo
Matching liquid placebo, 0 mcg x 2 pumps administered orally twice daily (BID)
Eligibility Criteria
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Inclusion Criteria
* Willing to discontinue use of prescribed or over-the-counter (OTC) medication that affects gastrointestinal motility during the study
* Stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors
Exclusion Criteria
* Medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication.
18 Years
ALL
No
Sponsors
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Sucampo Pharma Americas, LLC
INDUSTRY
Takeda
INDUSTRY
Sucampo AG
INDUSTRY
Mallinckrodt
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Mallinckrodt
Locations
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Anniston, Alabama, United States
Anaheim, California, United States
DeLand, Florida, United States
Hollywood, Florida, United States
Orlando, Florida, United States
South Miami, Florida, United States
Overland Park, Kansas, United States
Marlton, New Jersey, United States
Raleigh, North Carolina, United States
Salt Lake City, Utah, United States
West Bend, Wisconsin, United States
Countries
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Other Identifiers
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SCMP-0211-301
Identifier Type: -
Identifier Source: org_study_id