Study of Elobixibat (A3309) in Patients With Chronic Idiopathic Constipation

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to determine the efficacy and safety of A3309 administered to patients with chronic idiopathic constipation.

Official Title
-----------------
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

Conditions
-----------------
Constipation, Chronic Constipation

Intervention / Treatment
-----------------
* Drug: A3309


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A3309 low dose<br>Administered once daily for the duration of the study | Drug: A3309<br>* A3309 in three different dosage levels or placebo once daily for the duration of the study<br>|
| Experimental: A3309 intermediate dose<br>Administered once daily for the duration of the study. | Drug: A3309<br>* A3309 in three different dosage levels or placebo once daily for the duration of the study<br>|
| Experimental: A3309 high dose<br>Administered once daily for the duration of the study | Drug: A3309<br>* A3309 in three different dosage levels or placebo once daily for the duration of the study<br>|
| Placebo Comparator: Placebo<br>Administered once daily for the duration of the study | Drug: A3309<br>* A3309 in three different dosage levels or placebo once daily for the duration of the study<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Frequency of Spontaneous Bowel Movements | Primary ep W 1 | Baseline, weekly, up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder Analyses for Complete Spontaneous Bowel Movements (CSBMs) | 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 | Baseline, weekly and up to 8 weeks | 
| Time to First Bowel Movement |  | First week | 
| Stool Consistency Change From Baseline | Bristol Stool Form Scale. Min value:1. Max value: 7. Higher value indicates more liquid shape than normal, lower indicates constipated state. | Baseline, weekly and up to 8 weeks | 
| LDL/HDL Ratio | Ratio of plasma LDL cholesterol and HDL cholesterol Difference from baseline, placebo-adjusted | Baseline and 8 weeks of treatment | 
| Straining Change From Baseline | Daily assessment of straining. Min value: 1. Max value: 5. Higher value indicates more straining. | Baseline and during 8 weeks of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic idiopathic constipation, A3309