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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A3384 Low dose | Experimental | Administered twice daily for the duration of the study |
|
| A3384 High dose | Experimental | Administered twice daily for the duration of the study |
|
| Placebo | Placebo Comparator | Administered twice daily for the duration of the study |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A3384 | Drug |
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| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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).
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska Academy | Gothenburg | Sweden | ||||
| Kärnsjukhuset |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications.
Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
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Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
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| Baseline and 2 weeks |
| Skövde |
| Sweden |
| Hammersmith Hospital, Imperial College Healthcare NHS Trust | London | W12 0HS | United Kingdom |