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

Bile Acid Malabsorption Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02078856
• Other study ID #: A3384-001
• Status: Completed
• Phase: Phase 2
• Start date: March 2014
• Est. completion date: December 2014

Study information

• Verified date: March 2024
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bile Acid Malabsorption
• Malabsorption Syndromes

Intervention

Drug:
• A3384

Locations

Country	Name	City	State
Sweden	Sahlgrenska Academy	Göteborg
Sweden	Kärnsjukhuset	Skövde
United Kingdom	Hammersmith Hospital, Imperial College Healthcare NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Albireo

Countries where clinical trial is conducted

Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	Baseline and 2 weeks