Study of Elobixibat (A3309) in Patients With Chronic Idiopathic Constipation
- Registration Number
- NCT01007123
- Lead Sponsor
- Albireo
- Brief Summary
The purpose of this trial is to determine the efficacy and safety of A3309 administered to patients with chronic idiopathic constipation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 190
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A3309 low dose A3309 Administered once daily for the duration of the study A3309 intermediate dose A3309 Administered once daily for the duration of the study. A3309 high dose A3309 Administered once daily for the duration of the study Placebo A3309 Administered once daily for the duration of the study
- Primary Outcome Measures
Name Time Method Change From Baseline in Frequency of Spontaneous Bowel Movements Baseline, weekly, up to 8 weeks Primary ep W 1
- Secondary Outcome Measures
Name Time Method Time to First Bowel Movement First week Stool Consistency Change From Baseline Baseline, weekly and up to 8 weeks Bristol Stool Form Scale. Min value:1. Max value: 7. Higher value indicates more liquid shape than normal, lower indicates constipated state.
LDL/HDL Ratio Baseline and 8 weeks of treatment Ratio of plasma LDL cholesterol and HDL cholesterol Difference from baseline, placebo-adjusted
Straining Change From Baseline Baseline and during 8 weeks of treatment Daily assessment of straining. Min value: 1. Max value: 5. Higher value indicates more straining.
Responder Analyses for Complete Spontaneous Bowel Movements (CSBMs) Baseline, weekly and up to 8 weeks A CSBM responder is defined as per FDA draft guidance for IBS-C: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
Trial Locations
- Locations (1)
Albireo Investigative Site
🇺🇸La Crosse, Wisconsin, United States