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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
279
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
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
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
SK Chemicals
Seoul, South Korea
Global Assessment of Relief During the Double-Blind Treatment Phase Using the Subject Global Assessment (SGA)
Time frame: 12 weeks
Patient satisfaction using 5- Likert Scale
Time frame: 4 weeks
Subject Self Reported Adequate Relief of Pain
Time frame: 4 weeks
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey
Time frame: 12 weeks
Visual Analog Scale (VAS)
Time frame: 4 weeks
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