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

February 1, 2017 updated by: Albireo

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

190

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Albireo Investigative Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Albireo Investigative Site
      • Phoenix, Arizona, United States, 85020
        • Albireo Investigative Site
    • California
      • Anaheim, California, United States, 92801
        • Albireo Investigative Site
      • Encinitas, California, United States, 92024
        • Albireo Investigative Site
      • San Diego, California, United States, 92108
        • Albireo Investigative Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80904
        • Albireo Investigative Site
    • Florida
      • Boynton Beach, Florida, United States, 33426
        • Albireo Investigative Site
      • Inverness, Florida, United States, 34452
        • Albireo Investigative Site
    • Illinois
      • Peoria, Illinois, United States, 61602
        • Albireo Investigative Site
    • Iowa
      • Clive, Iowa, United States, 50325
        • Albireo Investigative Site
      • Davenport, Iowa, United States, 52807
        • Albireo Investigative Site
    • Kansas
      • Mission, Kansas, United States, 66202
        • Albireo Investigative Site
      • Overland Park, Kansas, United States, 66215
        • Albireo Investigative Site
    • Louisiana
      • Monroe, Louisiana, United States, 71201
        • Albireo Investigative Site
      • Shreveport, Louisiana, United States, 71103
        • Albireo Investigative Site
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Albireo Investigative Site
      • Baltimore, Maryland, United States, 21215
        • Albireo Investigative Site
      • Hollywood, Maryland, United States, 20636
        • Albireo Investigative Site
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Albireo Investigative Site
    • Nevada
      • Henderson, Nevada, United States, 89104
        • Albireo Investigative Site
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Albireo Investigative Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Albireo Investigative Site
    • New York
      • Great Neck, New York, United States, 11021
        • Albireo Investigative Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Albireo Investigative Site
      • Greensboro, North Carolina, United States, 27408
        • Albireo Investigative Site
      • Harrisburg, North Carolina, United States, 28075
        • Albireo Investigative Site
      • Statesville, North Carolina, United States, 28625
        • Albireo Investigative Site
      • Winston-Salem, North Carolina, United States, 27103
        • Albireo Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45224
        • Albireo Investigative Site
      • Cincinnati, Ohio, United States, 45242
        • Albireo Investigative Site
      • Dayton, Ohio, United States, 45440
        • Albireo Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • Albireo Investigative Site
    • Pennsylvania
      • Levittown, Pennsylvania, United States, 19056
        • Albireo Investigative Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Albireo Investigative Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37411
        • Albireo Investigative Site
      • Kingsport, Tennessee, United States, 37660
        • Albireo Investigative Site
    • Texas
      • El Paso, Texas, United States, 79905
        • Albireo Investigative Site
      • Longview, Texas, United States, 75605
        • Albireo Investigative Site
      • San Antonio, Texas, United States, 78229
        • Albireo Investigative Site
    • Utah
      • Ogden, Utah, United States, 84405
        • Albireo Investigative Site
      • Salt Lake City, Utah, United States, 84107
        • Albireo Investigative Site
    • Virginia
      • Lynchburg, Virginia, United States, 24502
        • Albireo Investigative Site
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Albireo Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A3309 low dose
Administered once daily for the duration of the study
Drug: A3309
A3309 in three different dosage levels or placebo once daily for the duration of the study
Experimental: A3309 intermediate dose
Administered once daily for the duration of the study.
Drug: A3309
A3309 in three different dosage levels or placebo once daily for the duration of the study
Experimental: A3309 high dose
Administered once daily for the duration of the study
Drug: A3309
A3309 in three different dosage levels or placebo once daily for the duration of the study
Placebo Comparator: Placebo
Administered once daily for the duration of the study
Drug: A3309
A3309 in three different dosage levels or placebo once daily for the duration of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Frequency of Spontaneous Bowel Movements
Time Frame: Baseline, weekly, up to 8 weeks
Primary ep W 1
Baseline, weekly, up to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Responder Analyses for Complete Spontaneous Bowel Movements (CSBMs)
Time Frame: Baseline, weekly and up to 8 weeks

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
Baseline, weekly and up to 8 weeks
Time to First Bowel Movement
Time Frame: First week
First week
Stool Consistency Change From Baseline
Time Frame: Baseline, weekly and up to 8 weeks
Bristol Stool Form Scale. Min value:1. Max value: 7. Higher value indicates more liquid shape than normal, lower indicates constipated state.
Baseline, weekly and up to 8 weeks
LDL/HDL Ratio
Time Frame: Baseline and 8 weeks of treatment
Ratio of plasma LDL cholesterol and HDL cholesterol Difference from baseline, placebo-adjusted
Baseline and 8 weeks of treatment
Straining Change From Baseline
Time Frame: Baseline and during 8 weeks of treatment
Daily assessment of straining. Min value: 1. Max value: 5. Higher value indicates more straining.
Baseline and during 8 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albireo

Investigators

  • Study Chair: Hans Graffner, MD, Albireo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

November 2, 2009

First Submitted That Met QC Criteria

November 2, 2009

First Posted (Estimate)

November 3, 2009

Study Record Updates

Last Update Posted (Actual)

March 22, 2017

Last Update Submitted That Met QC Criteria

February 1, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3309-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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