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

Primary Purpose

Non-constipation Irritable Bowel Syndrome

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

SKI3246 Low Dose

SKI3246 High Dose

Placebo

About this trial

This is an interventional treatment trial for Non-constipation Irritable Bowel Syndrome

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

SK Chemicals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

SKI3246 Low Dose

SKI3246 High Dose

Placebo

Arm Description

Intervention: Drug: SKI3246 Low Dose

Intervention: Drug: SKI3246 High Dose

Intervention: Drug: Placebo

Outcomes

Primary Outcome Measures

Global Assessment of Relief During the Double-Blind Treatment Phase Using the Subject Global Assessment (SGA)

Secondary Outcome Measures

Patient satisfaction using 5- Likert Scale

Subject Self Reported Adequate Relief of Pain

Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey

Visual Analog Scale (VAS)

Full Information

NCT ID

NCT02079675

First Posted

March 4, 2014

Last Updated

May 29, 2015

Sponsor

SK Chemicals Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02079675

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SK Chemicals Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-constipation Irritable Bowel Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

279 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SKI3246 Low Dose

Arm Type

Experimental

Arm Description

Intervention: Drug: SKI3246 Low Dose

Arm Title

SKI3246 High Dose

Arm Type

Experimental

Arm Description

Intervention: Drug: SKI3246 High Dose

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention: Drug: Placebo

Intervention Type

Drug

Intervention Name(s)

SKI3246 Low Dose

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

SKI3246 High Dose

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Global Assessment of Relief During the Double-Blind Treatment Phase Using the Subject Global Assessment (SGA)

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Patient satisfaction using 5- Likert Scale

Time Frame

4 weeks

Title

Subject Self Reported Adequate Relief of Pain

Time Frame

4 weeks

Title

Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey

Time Frame

12 weeks

Title

Visual Analog Scale (VAS)

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hyo Jin Park, M.D.

Organizational Affiliation

Gangnam Severance Hospital, Yonsei University College of Medicine

Official's Role

Study Chair

Facility Information:

Facility Name

SK Chemicals

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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