Double-blind, Randomised Study of A3384 in BAM/BAD

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Albireo
Sponsor:
Information provided by (Responsible Party):
Albireo
ClinicalTrials.gov Identifier:
NCT02078856
First received: March 3, 2014
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

The purpose of this trial is to determine the efficacy and safety of A3384 administered to patients with Bile Acid Malabsorption (BAM)/Bile Acid Diarrhoea (BAD).


Condition Intervention Phase
Bile Acid Malabsorption
Drug: A3384
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Placebo-controlled, Multi-centre, Dose-finding Efficacy and Safety Study of a Range of Doses of A3384 in Patients With Bile Acid Malabsorption (BAM)/Bile Acid Diarrhoea (BAD)

Resource links provided by NLM:


Further study details as provided by Albireo:

Primary Outcome Measures:
  • The primary efficacy objective of this study is to demonstrate the efficacy of different daily doses of A3384 as determined by the # of bowel movements (BMs). [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary efficacy objectives of this study are to demonstrate the efficacy of different daily doses on other BM parameters and BAM/BAD symptoms [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]

    Change from Baseline in average severity of diarrhoea during the second treatment week (last 7 days of reporting).

    • Change from Baseline in average severity of abdominal discomfort during the second treatment week (last 7 days of reporting).
    • Change from Baseline in average severity of abdominal bloating during the second treatment week (last 7 days of reporting).
    • Change from Baseline in average BSFS during the second treatment week (last 7 days of reporting)


Estimated Enrollment: 36
Study Start Date: March 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A3384 Low dose
Administered twice daily for the duration of the study
Drug: A3384
Experimental: A3384 High dose
Administered twice daily for the duration of the study
Drug: A3384
Placebo Comparator: Placebo
Administered twice daily for the duration of the study
Drug: A3384

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient meets protocol specified criteria for Bile Acid Malabsorption/Bile Acid Diarrhoea
  • Patient has successfully completed study requirements with no clinically relevant findings for physical exam, ECG, laboratory tests 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 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: NCT02078856

Contacts
Contact: Hans Graffner, MD hans.graffner@albireopharma.com

Locations
United Kingdom
Hammersmith Hospital, Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom, W12 0HS
Contact: Richard Appleby, MD       r.appleby@imperial.ac.uk   
Principal Investigator: Julian R Walters, MBBS MA FRCP         
Sponsors and Collaborators
Albireo
  More Information

No publications provided

Responsible Party: Albireo
ClinicalTrials.gov Identifier: NCT02078856     History of Changes
Other Study ID Numbers: A3384-001
Study First Received: March 3, 2014
Last Updated: March 4, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on July 24, 2014