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

Primary Purpose

Constipation, Chronic Constipation

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
A3309
Sponsored by
Albireo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring Chronic idiopathic constipation, A3309

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site
  • Albireo Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

A3309 low dose

A3309 intermediate dose

A3309 high dose

Placebo

Arm Description

Administered once daily for the duration of the study

Administered once daily for the duration of the study.

Administered once daily for the duration of the study

Administered once daily for the duration of the study

Outcomes

Primary Outcome Measures

Change From Baseline in Frequency of Spontaneous Bowel Movements
Primary ep W 1

Secondary Outcome Measures

Responder Analyses for Complete Spontaneous Bowel Movements (CSBMs)
A CSBM responder is defined as per FDA draft guidance for IBS-C: An increase of one or more of CSBMs per week over baseline for at least 4 out of the 8 weeks of treatment
Time to First Bowel Movement
Stool Consistency Change From Baseline
Bristol Stool Form Scale. Min value:1. Max value: 7. Higher value indicates more liquid shape than normal, lower indicates constipated state.
LDL/HDL Ratio
Ratio of plasma LDL cholesterol and HDL cholesterol Difference from baseline, placebo-adjusted
Straining Change From Baseline
Daily assessment of straining. Min value: 1. Max value: 5. Higher value indicates more straining.

Full Information

First Posted
November 2, 2009
Last Updated
February 1, 2017
Sponsor
Albireo
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1. Study Identification

Unique Protocol Identification Number
NCT01007123
Brief Title
Study of Elobixibat (A3309) in Patients With Chronic Idiopathic Constipation
Acronym
ACCESS
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

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albireo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation, Chronic Constipation
Keywords
Chronic idiopathic constipation, A3309

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A3309 low dose
Arm Type
Experimental
Arm Description
Administered once daily for the duration of the study
Arm Title
A3309 intermediate dose
Arm Type
Experimental
Arm Description
Administered once daily for the duration of the study.
Arm Title
A3309 high dose
Arm Type
Experimental
Arm Description
Administered once daily for the duration of the study
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administered once daily for the duration of the study
Intervention Type
Drug
Intervention Name(s)
A3309
Intervention Description
A3309 in three different dosage levels or placebo once daily for the duration of the study
Primary Outcome Measure Information:
Title
Change From Baseline in Frequency of Spontaneous Bowel Movements
Description
Primary ep W 1
Time Frame
Baseline, weekly, up to 8 weeks
Secondary Outcome Measure Information:
Title
Responder Analyses for Complete Spontaneous Bowel Movements (CSBMs)
Description
A CSBM responder is defined as per FDA draft guidance for IBS-C: An increase of one or more of CSBMs per week over baseline for at least 4 out of the 8 weeks of treatment
Time Frame
Baseline, weekly and up to 8 weeks
Title
Time to First Bowel Movement
Time Frame
First week
Title
Stool Consistency Change From Baseline
Description
Bristol Stool Form Scale. Min value:1. Max value: 7. Higher value indicates more liquid shape than normal, lower indicates constipated state.
Time Frame
Baseline, weekly and up to 8 weeks
Title
LDL/HDL Ratio
Description
Ratio of plasma LDL cholesterol and HDL cholesterol Difference from baseline, placebo-adjusted
Time Frame
Baseline and 8 weeks of treatment
Title
Straining Change From Baseline
Description
Daily assessment of straining. Min value: 1. Max value: 5. Higher value indicates more straining.
Time Frame
Baseline and during 8 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Graffner, MD
Organizational Affiliation
Albireo
Official's Role
Study Chair
Facility Information:
Facility Name
Albireo Investigative Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Albireo Investigative Site
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Albireo Investigative Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Albireo Investigative Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Albireo Investigative Site
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Albireo Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Albireo Investigative Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80904
Country
United States
Facility Name
Albireo Investigative Site
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Albireo Investigative Site
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Albireo Investigative Site
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Albireo Investigative Site
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Albireo Investigative Site
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52807
Country
United States
Facility Name
Albireo Investigative Site
City
Mission
State/Province
Kansas
ZIP/Postal Code
66202
Country
United States
Facility Name
Albireo Investigative Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Albireo Investigative Site
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Albireo Investigative Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Albireo Investigative Site
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Albireo Investigative Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Albireo Investigative Site
City
Hollywood
State/Province
Maryland
ZIP/Postal Code
20636
Country
United States
Facility Name
Albireo Investigative Site
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Albireo Investigative Site
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
Facility Name
Albireo Investigative Site
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Albireo Investigative Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Albireo Investigative Site
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Albireo Investigative Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Albireo Investigative Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Albireo Investigative Site
City
Harrisburg
State/Province
North Carolina
ZIP/Postal Code
28075
Country
United States
Facility Name
Albireo Investigative Site
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28625
Country
United States
Facility Name
Albireo Investigative Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Albireo Investigative Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45224
Country
United States
Facility Name
Albireo Investigative Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Albireo Investigative Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45440
Country
United States
Facility Name
Albireo Investigative Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
Albireo Investigative Site
City
Levittown
State/Province
Pennsylvania
ZIP/Postal Code
19056
Country
United States
Facility Name
Albireo Investigative Site
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Albireo Investigative Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37411
Country
United States
Facility Name
Albireo Investigative Site
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Albireo Investigative Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
Albireo Investigative Site
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
Albireo Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Albireo Investigative Site
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Albireo Investigative Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Albireo Investigative Site
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Facility Name
Albireo Investigative Site
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21606974
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. Erratum In: Am J Gastroenterol. 2014 May;109(5):782.
Results Reference
result

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

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