Bile Acid Malabsorption
Conditions
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).
Interventions
DRUGA3384
Sponsors
Albireo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | 2 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary efficacy objectives of this study are to demonstrate the efficacy of different daily doses on other BM parameters and BAM/BAD symptoms | Baseline and 2 weeks | 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) |
Countries
Sweden, United Kingdom
Outcome results
None listed