A randomised, double-blind, multicentre, international placebo-controlled phase II study aimed at investigating the efficacy and safety of a novel modified-release tablet formulation of colesevelam hydrochloride in patients with idiopathic bile acid diarrhoea (BAD)

idiopathic bile acid diarrhoea (BAD)

Proportion of study participants, who are stool consistency responders at Week 8 after T1 or T2 as compared to P. A stool consistency responder is defined as a participant who experiences a ≥50% reduction in the number of days with at least one stool that has a consistency of Type 6 or 7 in the 7-point Bristol Stool Form Scale (BSFS) compared with baseline.

01. Proportion of study participants, who are stool consistency responders at Week 2 and 4 after T1 or T2 as compared to P., 02. Proportion of study participants achieving remission of diarrhoea as per Hjortswang criteria, defined as <3 bowel movements per day and <1 stool per day with consistency of Type 6 or 7 in the 7-point BSFS calculated as the mean of the last 7 days prior to Week 8 after T1 or T2 as compared to P., 03. Proportion of study participants, who are stool frequency responders at Week 8 after T1 or T2 as compared to P. A stool frequency responder is defined as a participant, who experiences a ≥50% reduction in the number of days with ≥3 bowel movements compared with baseline, 04. Proportion of study participants who achieve remission in urgency, defined as a score of <3 in the urgency numerical rating scale at Week 2, 4 and 8 after treatment with T1 or T2 as compared to P., 05. To compare between treatments the proportion of patients with and the number of adverse drug reactions after 8 weeks of treatment.

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