Study to Assess the Efficacy and Safety of SKI3246 in Subjects With Non-Constipation Irritable Bowel Syndrome

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy and safety of different doses of SKI3246 compared with placebo in the treatment of patients with irritable bowel syndrome with non-constipation.

Official Title
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Multi-center, Randomized, Double Blinded, Parallel Group, Placebo-controlled, Phase II Trial to Assess the Efficacy and Safety of SKI3246 in Subjects With Non-Constipation Irritable Bowel Syndrome

Conditions
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Non-constipation Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: SKI3246 Low Dose
* Drug: SKI3246 High Dose
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have been diagnosed as non-constipation by ROME III. Patients who voluntarily signed written informed consent may participate in the study. Exclusion Criteria: Pregnant or lactating female. Patients with a history of inflammatory bowel disease. Severe neurological or psychological disease History of allergic reaction to the medications used in this study Use of other investigational drugs within 30 days prior to the study. Patients that investigators consider ineligible for this study

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: SKI3246 Low Dose<br>Intervention: Drug: SKI3246 Low Dose | Drug: SKI3246 Low Dose<br>* SKI3246 Low Dose will be taken for a 4-week duration (28 days) as 4 capsules a day: two capsules in the morning and two capsule in the evening<br>|
| Experimental: SKI3246 High Dose<br>Intervention: Drug: SKI3246 High Dose | Drug: SKI3246 High Dose<br>* SKI3246 High Dose will be taken for a 4-week duration (28 days) as 4 capsules a day: two capsules in the morning and two capsule in the evening<br>|
| Placebo Comparator: Placebo<br>Intervention: Drug: Placebo | Drug: Placebo<br>* SKI3246 Placebo will be taken for a 4-week duration (28 days) as 4 capsules a day: two capsules in the morning and two capsule in the evening<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Assessment of Relief During the Double-Blind Treatment Phase Using the Subject Global Assessment (SGA) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction using 5- Likert Scale |  | 4 weeks | 
| Subject Self Reported Adequate Relief of Pain |  | 4 weeks | 
| Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey |  | 12 weeks | 
| Visual Analog Scale (VAS) |  | 4 weeks |