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Completed

NCT Number: NCT01007123

Study of Elobixibat (A3309) 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.

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Key information

Conditions

Constipation Chronic Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Albireo Investigative Site, Huntsville, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A3309

Drug

A3309 in three different dosage levels or placebo once daily for the duration of the study

Primary outcomes

  1. Change From Baseline in Frequency of Spontaneous Bowel Movements

    Time frame: Baseline, weekly, up to 8 weeks

    Primary ep W 1

Secondary outcomes

  1. 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    A CSBM responder is defined as per FDA draft guidance for IBS-C: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

  2. Time to First Bowel Movement

    Time frame: First week

  3. 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.

  4. LDL/HDL Ratio

    Time frame: Baseline and 8 weeks of treatment

    Ratio of plasma LDL cholesterol and HDL cholesterol Difference from baseline, placebo-adjusted

  5. 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.

Sponsors and collaborators

Lead sponsor

Albireo

Industry

Registry information

Official study 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

Acronym: ACCESS

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 3, 2009
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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