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

Phase 2CompletedNCT02078856

Albireo19 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Bile Acid Malabsorption

Interventions

A3384DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (3)

Sahlgrenska Academy

Gothenburg, Sweden

Kärnsjukhuset

Skövde, Sweden

Hammersmith Hospital, Imperial College Healthcare NHS Trust

London, United Kingdom

Outcomes

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

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)

Time frame: Baseline and 2 weeks

Data from ClinicalTrials.gov

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