Clinical trial

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)

NCT02078856

Name

A3384-001

Description

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).

Trial arms

Trial start

2014-03-01

Estimated PCD

2014-12-01

Trial end

2014-12-01

Status

Completed

Phase

Early phase I

Treatment

A3384

Arms:

A3384 High dose, A3384 Low dose, Placebo

Size

Primary endpoint

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

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 19, 'type': 'ACTUAL'}}

Updated at

2024-03-07

1 organization

1 product

1 indication

Organization

Albireo

Product

A3384

Indication

Bile Acid Malabsorption