CompletedPhase 2

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

Sweden, United Kingdom19 participantsStarted 2014-03

Plain-language 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).

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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).

Timeframe: 2 weeks

Trial details

NCT IDNCT02078856

SponsorAlbireo

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-12

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