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

Phase 2

Completed

• Conditions: Bile Acid Malabsorption
• Interventions: Drug: A3384

• Registration Number: NCT02078856
• Lead Sponsor: Albireo

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-03
• Study First Submitted QC: 2014-03-04
• Study First Posted: 2014-03-05
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A3384 Low dose	A3384	Administered twice daily for the duration of the study
A3384 High dose	A3384	Administered twice daily for the duration of the study
Placebo	A3384	Administered twice daily for the duration of the study

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (3)

Kärnsjukhuset; 🇸🇪 Skövde, Sweden

Sahlgrenska Academy; 🇸🇪 Göteborg, Sweden

Hammersmith Hospital, Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom