Study of Elobixibat (A3309) in Patients With Chronic Idiopathic Constipation

NCT ID: NCT01007123

Last Updated: 2017-03-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-10-31

Brief Summary

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The purpose of this trial is to determine the efficacy and safety of A3309 administered to patients with chronic idiopathic constipation.

Detailed Description

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Conditions

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Constipation Chronic Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A3309 low dose

Administered once daily for the duration of the study

Group Type EXPERIMENTAL

A3309

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

A3309

Intervention Type DRUG

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

Group Type EXPERIMENTAL

A3309

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

A3309

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient meets protocol specified criteria for constipation
* Patient has successfully completed study requirements with no clinically relevant findings for physical exam, ECG, laboratory tests and colonoscopy as applicable

Exclusion Criteria

* Medical history or medical condition that would not make the patient a good candidate for the study or limit the patient´s ability to complete the study
* Patient reports loose stools
* Patient has IBS with pain/discomfort as predominant symptom
* Patient needs medications prohibited as specified in the protocol
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Albireo

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Albireo Investigative Site

Chandler, Arizona, United States

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Phoenix, Arizona, United States

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Anaheim, California, United States

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Encinitas, California, United States

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San Diego, California, United States

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Colorado Springs, Colorado, United States

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Boynton Beach, Florida, United States

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Inverness, Florida, United States

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Peoria, Illinois, United States

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Clive, Iowa, United States

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Davenport, Iowa, United States

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Mission, Kansas, United States

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Overland Park, Kansas, United States

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Monroe, Louisiana, United States

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Shreveport, Louisiana, United States

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Annapolis, Maryland, United States

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Baltimore, Maryland, United States

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Hollywood, Maryland, United States

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Chesterfield, Michigan, United States

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Henderson, Nevada, United States

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Marlton, New Jersey, United States

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Albuquerque, New Mexico, United States

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Great Neck, New York, United States

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Charlotte, North Carolina, United States

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Greensboro, North Carolina, United States

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Harrisburg, North Carolina, United States

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Statesville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Levittown, Pennsylvania, United States

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Anderson, South Carolina, United States

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Chattanooga, Tennessee, United States

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Kingsport, Tennessee, United States

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El Paso, Texas, United States

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Longview, Texas, United States

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San Antonio, Texas, United States

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Ogden, Utah, United States

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Salt Lake City, Utah, United States

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Albireo Investigative Site

Lynchburg, Virginia, United States

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Albireo Investigative Site

La Crosse, Wisconsin, United States

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Countries

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United States

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.

Reference Type RESULT
PMID: 21606974 (View on PubMed)

Other Identifiers

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A3309-002

Identifier Type: -

Identifier Source: org_study_id

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