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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Albireo
ClinicalTrials.gov Identifier:
NCT01007123
First received: November 2, 2009
Last updated: February 1, 2017
Last verified: February 2017
  Purpose
The purpose of this trial is to determine the efficacy and safety of A3309 administered to patients with chronic idiopathic constipation.

Condition Intervention Phase
Constipation
Chronic Constipation
Drug: A3309
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Albireo:

Primary Outcome Measures:
  • Change From Baseline in Frequency of Spontaneous Bowel Movements [ Time Frame: Baseline, weekly, up to 8 weeks ]
    Primary ep W 1


Secondary Outcome Measures:
  • 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    A CSBM responder is defined as per FDA draft guidance for IBS-C: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


  • Time to First Bowel Movement [ Time Frame: 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.

  • LDL/HDL Ratio [ Time Frame: Baseline and 8 weeks of treatment ]
    Ratio of plasma LDL cholesterol and HDL cholesterol Difference from baseline, placebo-adjusted

  • 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.


Enrollment: 190
Study Start Date: November 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01007123

  Show 44 Study Locations
Sponsors and Collaborators
Albireo
Investigators
Study Chair: Hans Graffner, MD Albireo
  More Information

Publications:
Responsible Party: Albireo
ClinicalTrials.gov Identifier: NCT01007123     History of Changes
Other Study ID Numbers: A3309-002
Study First Received: November 2, 2009
Results First Received: November 1, 2016
Last Updated: February 1, 2017

Keywords provided by Albireo:
Chronic idiopathic constipation
A3309

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on March 29, 2017