Clinical trial NCT01007123: Study of Elobixibat (A3309) in Patients With Chronic Idiopathic Constipation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Constipation
Chronic Constipation
Keywords: Chronic idiopathic constipation
A3309
Lead sponsor: AlbireoPharma
Sponsor class: UNKNOWN
First posted: 2009-11-03
Enrollment: 190
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Frequency of Spontaneous Bowel Movements
timeFrame: Baseline, weekly, up to 8 weeks
Secondary outcomes:
measure: Responder Analyses for Complete Spontaneous Bowel Movements (CSBMs)
timeFrame: Baseline, weekly and up to 8 weeks
measure: Time to First Bowel Movement
timeFrame: First week
measure: Stool Consistency Change From Baseline
timeFrame: Baseline, weekly and up to 8 weeks
measure: LDL/HDL Ratio
timeFrame: Baseline and 8 weeks of treatment
measure: Straining Change From Baseline
timeFrame: Baseline and during 8 weeks of treatment
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Albireo Investigative Site
state: Alabama
city: Chandler
country: United States
facility: Albireo Investigative Site
state: Arizona
city: Phoenix
country: United States
facility: Albireo Investigative Site
state: Arizona
city: Anaheim
country: United States
facility: Albireo Investigative Site
state: California
city: Encinitas
country: United States
facility: Albireo Investigative Site
state: California
city: San Diego
country: United States
facility: Albireo Investigative Site
state: California
city: Colorado Springs
country: United States
facility: Albireo Investigative Site
state: Colorado
city: Boynton Beach
country: United States
facility: Albireo Investigative Site
state: Florida
city: Inverness
country: United States
facility: Albireo Investigative Site
state: Florida
city: Peoria
country: United States
facility: Albireo Investigative Site
state: Illinois
city: Clive
country: United States
facility: Albireo Investigative Site
state: Iowa
city: Davenport
country: United States
facility: Albireo Investigative Site
state: Iowa
city: Mission
country: United States
facility: Albireo Investigative Site
state: Kansas
city: Overland Park
country: United States
facility: Albireo Investigative Site
state: Kansas
city: Monroe
country: United States
facility: Albireo Investigative Site
state: Louisiana
city: Shreveport
country: United States
facility: Albireo Investigative Site
state: Louisiana
city: Annapolis
country: United States
facility: Albireo Investigative Site
state: Maryland
city: Baltimore
country: United States
facility: Albireo Investigative Site
state: Maryland
city: Hollywood
country: United States
facility: Albireo Investigative Site
state: Maryland
city: Chesterfield
country: United States
facility: Albireo Investigative Site
state: Michigan
city: Henderson
country: United States
facility: Albireo Investigative Site
state: Nevada
city: Marlton
country: United States
facility: Albireo Investigative Site
state: New Jersey
city: Albuquerque
country: United States
facility: Albireo Investigative Site
state: New Mexico
city: Great Neck
country: United States
facility: Albireo Investigative Site
state: New York
city: Charlotte
country: United States
facility: Albireo Investigative Site
state: North Carolina
city: Greensboro
country: United States
facility: Albireo Investigative Site
state: North Carolina
city: Harrisburg
country: United States
facility: Albireo Investigative Site
state: North Carolina
city: Statesville
country: United States
facility: Albireo Investigative Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Albireo Investigative Site
state: North Carolina
city: Cincinnati
country: United States
facility: Albireo Investigative Site
state: Ohio
city: Cincinnati
country: United States
facility: Albireo Investigative Site
state: Ohio
city: Dayton
country: United States
facility: Albireo Investigative Site
state: Ohio
city: Oklahoma City
country: United States
facility: Albireo Investigative Site
state: Oklahoma
city: Levittown
country: United States
facility: Albireo Investigative Site
state: Pennsylvania
city: Anderson
country: United States
facility: Albireo Investigative Site
state: South Carolina
city: Chattanooga
country: United States
facility: Albireo Investigative Site
state: Tennessee
city: Kingsport
country: United States
facility: Albireo Investigative Site
state: Tennessee
city: El Paso
country: United States
facility: Albireo Investigative Site
state: Texas
city: Longview
country: United States
facility: Albireo Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Albireo Investigative Site
state: Texas
city: Ogden
country: United States
facility: Albireo Investigative Site
state: Utah
city: Salt Lake City
country: United States
facility: Albireo Investigative Site
state: Utah
city: Lynchburg
country: United States
facility: Albireo Investigative Site
state: Virginia
city: La Crosse
country: United States
facility: Albireo Investigative Site
state: Wisconsin
Study officials:
affiliation: Albireo
name: Hans Graffner, MD
role: STUDY_CHAIR
References:
citation: 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.