Asimadoline for the Treatment of Subjects With Irritable Bowel Syndrome

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of different doses of asimadoline in the treatment of patients with irritable bowel syndrome.

Detailed Description
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A randomized, dose-ranging, double-blind, placebo-controlled study designed to evaluate the efficacy and tolerability of three dose levels of asimadoline in subjects with IBS.

Official Title
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A 12-Week, Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled Study of Asimadoline in Subjects With Irritable Bowel Syndrome

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: Asimadoline
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females aged 18-79 Must sign an ICF Females of childbearing potential must have a negative pregnancy test at screening and must adhere to contraception throughout the trial Must have been diagnosed with IBS as a result of having at least 6 months, not necessarily consecutive, in the preceding 12 months of recurrent symptoms of abdominal discomfort or pain associated with at least 2 of the following: 1)relieved with defecation; 2)onset associated with a change in stool frequency; 3)onset associated with a change in stool form Must demonstrate a willingness to comply with daily telephone diary entry Exclusion Criteria: Any subject with evidence of a biochemical or structural abnormality of the digestive tract or other co-morbid illness that might impact the ability to interpret the safety and efficacy data Pregnant or breastfeeding females Refusal to discontinue prohibited concomitant medications Use of an investigational drug or participation in an investigational study within 30 days of screening Inability or unwillingness to use the touch-tone telephone data entry system

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo was provided in coated tablets identical in appearance to asimadoline tablets.<br>|
| Experimental: Asimadoline 0.15 mg<br> | Drug: Asimadoline<br>* Asimadoline was provided in coated tablets of three dosages (0.15 mg, 0.5 mg, and 1.0 mg). All asimadoline tablets used in this trial were synthesized from the same batch of drug substance (Batch EF418492). Asimadoline was administered orally, BID for 12 weeks<br>* Other names: EMR 63320;|
| Experimental: Asimadoline 0.5 mg<br> | Drug: Asimadoline<br>* Asimadoline was provided in coated tablets of three dosages (0.15 mg, 0.5 mg, and 1.0 mg). All asimadoline tablets used in this trial were synthesized from the same batch of drug substance (Batch EF418492). Asimadoline was administered orally, BID for 12 weeks<br>* Other names: EMR 63320;|
| Experimental: Asimadoline 1.0 mg<br> | Drug: Asimadoline<br>* Asimadoline was provided in coated tablets of three dosages (0.15 mg, 0.5 mg, and 1.0 mg). All asimadoline tablets used in this trial were synthesized from the same batch of drug substance (Batch EF418492). Asimadoline was administered orally, BID for 12 weeks<br>* Other names: EMR 63320;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief of IBS Pain - total months | The primary efficacy endpoint of the study was the total number of months with adequate relief of IBS pain or discomfort. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief of IBS Pain - percent of patients | Proportion of subjects with adequate relief of IBS pain or discomfort | 12 weeks | 
| Relief of IBS Symptoms | Adequate relief of IBS symptoms | 12 weeks | 
| Lower GI function - change from baseline | Change from baseline in assessments of lower gastrointestinal (GI) function (i.e., stool frequency, stool consistency, urgency, bloating, and straining) | 12 weeks | 
| Abdominal Pain Score - change from baseline | Change from baseline in abdominal pain score | 12 weeks | 
| Abdominal Discomfort Score - change from baseline | Change from baseline in abdominal discomfort score | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irritable Bowel Syndrome, Asimadoline