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

SK chemicals

Status and phase: Completed; Phase 2

Conditions: Non-constipation Irritable Bowel Syndrome

Treatments: Drug: SKI3246 High Dose; Drug: Placebo; Drug: SKI3246 Low Dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02079675

SKI3246_IBS_II_2012

Details and patient eligibility

About

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.

Enrollment: 279 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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279 participants in 3 patient groups, including a placebo group

SKI3246 Low Dose

Experimental group

Description:

Intervention: Drug: SKI3246 Low Dose

Treatment:

Drug: SKI3246 Low Dose

SKI3246 High Dose

Experimental group

Description:

Intervention: Drug: SKI3246 High Dose

Treatment:

Drug: SKI3246 High Dose

Placebo

Placebo Comparator group

Description:

Intervention: Drug: Placebo

Treatment:

Drug: Placebo