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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SKI3246 Low Dose | Experimental | Intervention: Drug: SKI3246 Low Dose |
|
| SKI3246 High Dose | Experimental | Intervention: Drug: SKI3246 High Dose |
|
| Placebo | Placebo Comparator | Intervention: Drug: Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SKI3246 Low Dose | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global Assessment of Relief During the Double-Blind Treatment Phase Using the Subject Global Assessment (SGA) | 12 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyo Jin Park, M.D. | Gangnam Severance Hospital, Yonsei University College of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SK Chemicals | Seoul | South Korea |
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| SKI3246 High Dose | Drug | 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 |
|
| Placebo | Drug | 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 |
|
| 12 weeks |
| Visual Analog Scale (VAS) | 4 weeks |