Back to resultsDouble-blind, Randomised Study of A3384 in BAM/BAD
Primary Purpose
Bile Acid Malabsorption
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
A3384
Sponsored by
About this trial
This is an interventional treatment trial for Bile Acid Malabsorption
Eligibility 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
Sites / Locations
- Sahlgrenska Academy
- Kärnsjukhuset
- Hammersmith Hospital, Imperial College Healthcare NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
A3384 Low dose
A3384 High dose
Placebo
Arm Description
Administered twice daily for the duration of the study
Administered twice daily for the duration of the study
Administered twice daily for the duration of the study
Outcomes
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).
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
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02078856
Brief Title
Double-blind, Randomised Study of A3384 in BAM/BAD
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (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 A3384 administered to patients with Bile Acid Malabsorption (BAM)/Bile Acid Diarrhoea (BAD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bile Acid Malabsorption
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A3384 Low dose
Arm Type
Experimental
Arm Description
Administered twice daily for the duration of the study
Arm Title
A3384 High dose
Arm Type
Experimental
Arm Description
Administered twice daily for the duration of the study
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administered twice daily for the duration of the study
Intervention Type
Drug
Intervention Name(s)
A3384
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Secondary efficacy objectives of this study are to demonstrate the efficacy of different daily doses on other BM parameters and BAM/BAD symptoms
Description
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)
Time Frame
Baseline and 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Sahlgrenska Academy
City
Göteborg
Country
Sweden
Facility Name
Kärnsjukhuset
City
Skövde
Country
Sweden
Facility Name
Hammersmith Hospital, Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Double-blind, Randomised Study of A3384 in BAM/BAD
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