Title
Study of Elobixibat (A3309) in Patients With Chronic Idiopathic Constipation
A Phase IIb, Double-blind, Randomised, Placebo-controlled, Multi-centre, Dose-finding Efficacy and Safety Study of a Range of Doses of Elobixibat in Patients With Chronic Idiopathic Constipation
Phase
Phase 2Lead Sponsor
AlbireoStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Chronic Constipation ...Intervention/Treatment
elobixibat ...Study Participants
190The purpose of this trial is to determine the efficacy and safety of A3309 administered to patients with chronic idiopathic constipation.
A3309 in three different dosage levels or placebo once daily for the duration of the study
Administered once daily for the duration of the study.
Inclusion Criteria: Patient meets protocol specified criteria for constipation Patient has successfully completed study requirements with no clinically relevant findings for physical exam, ECG, laboratory tests and colonoscopy 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 reports loose stools Patient has IBS with pain/discomfort as predominant symptom Patient needs medications prohibited as specified in the protocol
| Event Type | Organ System | Event Term | Elobixibat (A3309) 5 mg | Elobixibat (A3309) 10 mg | Elobixibat (A3309) 15 mg | Placebo |
|---|
Primary ep W 1
A CSBM responder is defined as per FDA draft guidance for IBS-C: An increase of one or more of CSBMs per week over baseline for at least 4 out of the 8 weeks of treatment
Bristol Stool Form Scale. Min value:1. Max value: 7. Higher value indicates more liquid shape than normal, lower indicates constipated state.
Ratio of plasma LDL cholesterol and HDL cholesterol Difference from baseline, placebo-adjusted
Daily assessment of straining. Min value: 1. Max value: 5. Higher value indicates more straining.
