Study of Elobixibat (A3309) in Patients With Chronic Idiopathic Constipation
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A Phase IIb, Double-blind, Randomised, Placebo-controlled, Multi-centre, Dose-finding Efficacy and Safety Study of a Range of Doses of Elobixibat in Patients With Chronic Idiopathic Constipation
1 other identifier
interventional
190
1 country
44
Brief Summary
The purpose of this trial is to determine the efficacy and safety of A3309 administered to patients with chronic idiopathic constipation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2009
Shorter than P25 for phase_2
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 2, 2009
CompletedFirst Posted
Study publicly available on registry
November 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedResults Posted
Study results publicly available
March 22, 2017
CompletedMarch 22, 2017
February 1, 2017
11 months
November 2, 2009
November 1, 2016
February 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Frequency of Spontaneous Bowel Movements
Primary ep W 1
Baseline, weekly, up to 8 weeks
Secondary Outcomes (5)
Responder Analyses for Complete Spontaneous Bowel Movements (CSBMs)
Baseline, weekly and up to 8 weeks
Time to First Bowel Movement
First week
Stool Consistency Change From Baseline
Baseline, weekly and up to 8 weeks
LDL/HDL Ratio
Baseline and 8 weeks of treatment
Straining Change From Baseline
Baseline and during 8 weeks of treatment
Study Arms (4)
A3309 low dose
EXPERIMENTALAdministered once daily for the duration of the study
A3309 intermediate dose
EXPERIMENTALAdministered once daily for the duration of the study.
A3309 high dose
EXPERIMENTALAdministered once daily for the duration of the study
Placebo
PLACEBO COMPARATORAdministered once daily for the duration of the study
Interventions
A3309 in three different dosage levels or placebo once daily for the duration of the study
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Albireolead
Study Sites (44)
Albireo Investigative Site
Huntsville, Alabama, 35801, United States
Albireo Investigative Site
Chandler, Arizona, 85224, United States
Albireo Investigative Site
Phoenix, Arizona, 85020, United States
Albireo Investigative Site
Anaheim, California, 92801, United States
Albireo Investigative Site
Encinitas, California, 92024, United States
Albireo Investigative Site
San Diego, California, 92108, United States
Albireo Investigative Site
Colorado Springs, Colorado, 80904, United States
Albireo Investigative Site
Boynton Beach, Florida, 33426, United States
Albireo Investigative Site
Inverness, Florida, 34452, United States
Albireo Investigative Site
Peoria, Illinois, 61602, United States
Albireo Investigative Site
Clive, Iowa, 50325, United States
Albireo Investigative Site
Davenport, Iowa, 52807, United States
Albireo Investigative Site
Mission, Kansas, 66202, United States
Albireo Investigative Site
Overland Park, Kansas, 66215, United States
Albireo Investigative Site
Monroe, Louisiana, 71201, United States
Albireo Investigative Site
Shreveport, Louisiana, 71103, United States
Albireo Investigative Site
Annapolis, Maryland, 21401, United States
Albireo Investigative Site
Baltimore, Maryland, 21215, United States
Albireo Investigative Site
Hollywood, Maryland, 20636, United States
Albireo Investigative Site
Chesterfield, Michigan, 48047, United States
Albireo Investigative Site
Henderson, Nevada, 89104, United States
Albireo Investigative Site
Marlton, New Jersey, 08053, United States
Albireo Investigative Site
Albuquerque, New Mexico, 87108, United States
Albireo Investigative Site
Great Neck, New York, 11021, United States
Albireo Investigative Site
Charlotte, North Carolina, 28211, United States
Albireo Investigative Site
Greensboro, North Carolina, 27408, United States
Albireo Investigative Site
Harrisburg, North Carolina, 28075, United States
Albireo Investigative Site
Statesville, North Carolina, 28625, United States
Albireo Investigative Site
Winston-Salem, North Carolina, 27103, United States
Albireo Investigative Site
Cincinnati, Ohio, 45224, United States
Albireo Investigative Site
Cincinnati, Ohio, 45242, United States
Albireo Investigative Site
Dayton, Ohio, 45440, United States
Albireo Investigative Site
Oklahoma City, Oklahoma, 73116, United States
Albireo Investigative Site
Levittown, Pennsylvania, 19056, United States
Albireo Investigative Site
Anderson, South Carolina, 29621, United States
Albireo Investigative Site
Chattanooga, Tennessee, 37411, United States
Albireo Investigative Site
Kingsport, Tennessee, 37660, United States
Albireo Investigative Site
El Paso, Texas, 79905, United States
Albireo Investigative Site
Longview, Texas, 75605, United States
Albireo Investigative Site
San Antonio, Texas, 78229, United States
Albireo Investigative Site
Ogden, Utah, 84405, United States
Albireo Investigative Site
Salt Lake City, Utah, 84107, United States
Albireo Investigative Site
Lynchburg, Virginia, 24502, United States
Albireo Investigative Site
La Crosse, Wisconsin, 54601, United States
Related Publications (1)
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.
PMID: 21606974RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Mats Ekelund
- Organization
- Albireo
Study Officials
- STUDY CHAIR
Hans Graffner, MD
Albireo
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2009
First Posted
November 3, 2009
Study Start
November 1, 2009
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
March 22, 2017
Results First Posted
March 22, 2017
Record last verified: 2017-02