Study to Assess the Efficacy and Safety of SKI3246 in Subjects With Non-Constipation Irritable Bowel Syndrome
NCT ID: NCT02079675
Last Updated: 2015-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
279 participants
INTERVENTIONAL
2013-01-31
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SKI3246 Low Dose
Intervention: Drug: SKI3246 Low Dose
SKI3246 Low Dose
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
Intervention: Drug: SKI3246 High Dose
SKI3246 High Dose
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
Intervention: Drug: Placebo
Placebo
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
Interventions
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SKI3246 Low Dose
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
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
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
Eligibility Criteria
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Inclusion Criteria
* Patients who voluntarily signed written informed consent may participate in the study.
Exclusion Criteria
* 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
20 Years
75 Years
ALL
No
Sponsors
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SK Chemicals Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Hyo Jin Park, M.D.
Role: STUDY_CHAIR
Gangnam Severance Hospital, Yonsei University College of Medicine
Locations
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SK Chemicals
Seoul, , South Korea
Countries
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Other Identifiers
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SKI3246_IBS_II_2012
Identifier Type: -
Identifier Source: org_study_id
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