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

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).

Completed

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Key information

Conditions

Bile Acid Malabsorption

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sahlgrenska Academy, Gothenburg, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A3384

Drug

Primary outcomes

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 outcomes

Secondary efficacy objectives of this study are to demonstrate the efficacy of different daily doses on other BM parameters and BAM/BAD symptoms

Time frame: 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)

Sponsors and collaborators

Lead sponsor

Albireo

Industry

Registry information

Official study 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)

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Mar 5, 2014
Registry last updated: Mar 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed