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

Non-constipation Irritable Bowel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02079675
• Other study ID #: SKI3246_IBS_II_2012
• Status: Completed
• Phase: Phase 2
• First received: March 4, 2014
• Last updated: May 29, 2015
• Start date: January 2013
• Est. completion date: April 2014

Study information

• Verified date: May 2015
• Source: SK Chemicals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug SafetyKorea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 279
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Non-constipation Irritable Bowel Syndrome
• Syndrome

Intervention

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
• 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

Locations

Country	Name	City	State
Korea, Republic of	SK Chemicals	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
SK Chemicals Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Assessment of Relief During the Double-Blind Treatment Phase Using the Subject Global Assessment (SGA)		12 weeks	No
Secondary	Patient satisfaction using 5- Likert Scale		4 weeks	No
Secondary	Subject Self Reported Adequate Relief of Pain		4 weeks	No
Secondary	Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey		12 weeks	No
Secondary	Visual Analog Scale (VAS)		4 weeks	No