Clinical Trial: Double-blind, Randomised Study of A3384 in BAM/BAD
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
Brief 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).
Detailed Summary:
Sponsor: Albireo
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: 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)
Original Secondary Outcome: Same as current
Information By: Albireo
Dates:
Date Received: March 3, 2014
Date Started: March 2014
Date Completion:
Last Updated: October 12, 2016
Last Verified: October 2016