Study of Elobixibat (A3309) in Patients With Chronic Idiopathic Constipation
NCT ID: NCT01007123
Last Updated: 2017-03-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
190 participants
INTERVENTIONAL
2009-11-30
2010-10-31
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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A3309 low dose
Administered once daily for the duration of the study
A3309
A3309 in three different dosage levels or placebo once daily for the duration of the study
A3309 intermediate dose
Administered once daily for the duration of the study.
A3309
A3309 in three different dosage levels or placebo once daily for the duration of the study
A3309 high dose
Administered once daily for the duration of the study
A3309
A3309 in three different dosage levels or placebo once daily for the duration of the study
Placebo
Administered once daily for the duration of the study
A3309
A3309 in three different dosage levels or placebo once daily for the duration of the study
Interventions
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A3309
A3309 in three different dosage levels or placebo once daily for the duration of the study
Eligibility Criteria
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Inclusion Criteria
* Patient has successfully completed study requirements with no clinically relevant findings for physical exam, ECG, laboratory tests and colonoscopy as applicable
Exclusion Criteria
* Patient reports loose stools
* Patient has IBS with pain/discomfort as predominant symptom
* Patient needs medications prohibited as specified in the protocol
20 Years
80 Years
ALL
No
Sponsors
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Albireo
INDUSTRY
Responsible Party
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Principal Investigators
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Hans Graffner, MD
Role: STUDY_CHAIR
Albireo
Locations
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Albireo Investigative Site
Huntsville, Alabama, United States
Albireo Investigative Site
Chandler, Arizona, United States
Albireo Investigative Site
Phoenix, Arizona, United States
Albireo Investigative Site
Anaheim, California, United States
Albireo Investigative Site
Encinitas, California, United States
Albireo Investigative Site
San Diego, California, United States
Albireo Investigative Site
Colorado Springs, Colorado, United States
Albireo Investigative Site
Boynton Beach, Florida, United States
Albireo Investigative Site
Inverness, Florida, United States
Albireo Investigative Site
Peoria, Illinois, United States
Albireo Investigative Site
Clive, Iowa, United States
Albireo Investigative Site
Davenport, Iowa, United States
Albireo Investigative Site
Mission, Kansas, United States
Albireo Investigative Site
Overland Park, Kansas, United States
Albireo Investigative Site
Monroe, Louisiana, United States
Albireo Investigative Site
Shreveport, Louisiana, United States
Albireo Investigative Site
Annapolis, Maryland, United States
Albireo Investigative Site
Baltimore, Maryland, United States
Albireo Investigative Site
Hollywood, Maryland, United States
Albireo Investigative Site
Chesterfield, Michigan, United States
Albireo Investigative Site
Henderson, Nevada, United States
Albireo Investigative Site
Marlton, New Jersey, United States
Albireo Investigative Site
Albuquerque, New Mexico, United States
Albireo Investigative Site
Great Neck, New York, United States
Albireo Investigative Site
Charlotte, North Carolina, United States
Albireo Investigative Site
Greensboro, North Carolina, United States
Albireo Investigative Site
Harrisburg, North Carolina, United States
Albireo Investigative Site
Statesville, North Carolina, United States
Albireo Investigative Site
Winston-Salem, North Carolina, United States
Albireo Investigative Site
Cincinnati, Ohio, United States
Albireo Investigative Site
Cincinnati, Ohio, United States
Albireo Investigative Site
Dayton, Ohio, United States
Albireo Investigative Site
Oklahoma City, Oklahoma, United States
Albireo Investigative Site
Levittown, Pennsylvania, United States
Albireo Investigative Site
Anderson, South Carolina, United States
Albireo Investigative Site
Chattanooga, Tennessee, United States
Albireo Investigative Site
Kingsport, Tennessee, United States
Albireo Investigative Site
El Paso, Texas, United States
Albireo Investigative Site
Longview, Texas, United States
Albireo Investigative Site
San Antonio, Texas, United States
Albireo Investigative Site
Ogden, Utah, United States
Albireo Investigative Site
Salt Lake City, Utah, United States
Albireo Investigative Site
Lynchburg, Virginia, United States
Albireo Investigative Site
La Crosse, Wisconsin, United States
Countries
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References
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Chey WD, Camilleri M, Chang L, Rikner L, Graffner H. A randomized placebo-controlled phase IIb trial of a3309, a bile acid transporter inhibitor, for chronic idiopathic constipation. Am J Gastroenterol. 2011 Oct;106(10):1803-12. doi: 10.1038/ajg.2011.162. Epub 2011 May 24.
Other Identifiers
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A3309-002
Identifier Type: -
Identifier Source: org_study_id
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