A3384 in BAM/BAD
Research type
Research Study
Full title
A double-blind, randomized, placebo-controlled, study to demonstrate the efficacy and safety of 250 mg or 1 g A3384 administered orally twice daily for two weeks to patients with Bile Acid Malabsorption (BAM)/Bile Acid Diarrhoea (BAD)
IRAS ID
137510
Contact name
Julian Walters
Contact email
Sponsor organisation
Albireo AB
Eudract number
2013-002924-17
ISRCTN Number
NA
Clinicaltrials.gov Identifier
NA
Research summary
Patients diagnosed with Bile Acid Malabsorption (BAM) are experiencing diarrhoea symptoms due to malfunction in reabsorption of the bile acid secreted from their liver. If too much bile acid reaches the colon the colonic motility increases and the transit time through the intestine is shortened. Thereby symptoms like diarrhoea and other gastrointestinal discomforts such as bloating, urgency and faecal incontinence occur.
This study intends to find out if the investigational drug A3384 can help people with BAM suffering from diarrhoea. Capsules with investigational drug contain cholestyramine, a resin that can bind bile acid in the intestine and thereby diminish the amount of bile acid that reaches the large intestine. The tendency for diarrhoea to develop thereby diminishes. Cholestyramine has been used for the treatment of patients with symptoms of bile acid diarrhoea for many years. The capsules with investigational drug contain cholestyramine in a new formulation that is expected to be more effective than those today available. The study will evaluate two doses of A3384 with delayed colonic release of cholestyramine when given twice daily during 14 days. The two doses of the investigational drug 250 mg or 1 g will be randomized to placebo in 1:1:1 ratio and will be evaluated on safety and efficacy. It is planned that 36 individuals aged 18 and above will be enrolled into this study.
The primary efficacy objective is to demonstrate the efficacy of A3384 during the treatment period in patients with BAM, as determined by the # of bowel movements (BMs).
The primary safety objective is to assess the safety and tolerability of A3384 during the treatment period in patients with BAM, as determined by the occurrence of treatment-emergent SAEs.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
13/EM/0374
Date of REC Opinion
30 Oct 2013
REC opinion
Further Information Favourable Opinion