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

Phase 2

Completed

• Conditions: Non-constipation Irritable Bowel Syndrome
• Interventions: Drug: Placebo; Drug: SKI3246 High Dose; Drug: SKI3246 Low Dose

• Registration Number: NCT02079675
• Lead Sponsor: SK Chemicals Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2014-03
• Study First Submitted: 2014-03-04
• Study First Submitted QC: 2014-03-04
• Study First Posted: 2014-03-06
• Study Completion: 2014-04
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-29
• Last Update Posted: 2015-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 279

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Intervention: Drug: Placebo
SKI3246 High Dose	SKI3246 High Dose	Intervention: Drug: SKI3246 High Dose
SKI3246 Low Dose	SKI3246 Low Dose	Intervention: Drug: SKI3246 Low Dose

Primary Outcome Measures

Name	Time	Method
Global Assessment of Relief During the Double-Blind Treatment Phase Using the Subject Global Assessment (SGA)	12 weeks

Secondary Outcome Measures

Name	Time	Method
Subject Self Reported Adequate Relief of Pain	4 weeks
Patient satisfaction using 5- Likert Scale	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

Trial Locations

Locations (1)

SK Chemicals; 🇰🇷 Seoul, Korea, Republic of