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

Multi-center, Randomized, Double Blinded, Parallel Group, Placebo-controlled, Phase II Trial to Assess the Efficacy and Safety of SKI3246 in Subjects With Non-Constipation Irritable Bowel Syndrome

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 Overview

• Status: Completed
• Conditions: Non-constipation Irritable Bowel Syndrome
• Intervention / Treatment: Drug: SKI3246 Low Dose; Drug: SKI3246 High Dose; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 279
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • SK chemicals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SKI3246 Low Dose; Intervention: Drug: SKI3246 Low Dose	Drug: 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
Experimental: SKI3246 High Dose; Intervention: Drug: SKI3246 High Dose	Drug: 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 Comparator: Placebo; Intervention: Drug: Placebo	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Global Assessment of Relief During the Double-Blind Treatment Phase Using the Subject Global Assessment (SGA)	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Visual Analog Scale (VAS)	4 weeks
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	12 weeks

Collaborators and Investigators

• Sponsor: SK Chemicals Co., Ltd.
• Investigators: Study Chair: Hyo Jin Park, M.D., Gangnam Severance Hospital, Yonsei University College of Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: March 4, 2014
• First Submitted That Met QC Criteria: March 4, 2014
• First Posted (Estimate): March 6, 2014

Study Record Updates

• Last Update Posted (Estimate): June 1, 2015
• Last Update Submitted That Met QC Criteria: May 29, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: SKI3246_IBS_II_2012