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
1 other identifier
interventional
279
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2013
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 4, 2014
CompletedFirst Posted
Study publicly available on registry
March 6, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedJune 1, 2015
May 1, 2015
1.2 years
March 4, 2014
May 29, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Global Assessment of Relief During the Double-Blind Treatment Phase Using the Subject Global Assessment (SGA)
12 weeks
Secondary Outcomes (4)
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
Visual Analog Scale (VAS)
4 weeks
Study Arms (3)
SKI3246 Low Dose
EXPERIMENTALIntervention: Drug: SKI3246 Low Dose
SKI3246 High Dose
EXPERIMENTALIntervention: Drug: SKI3246 High Dose
Placebo
PLACEBO COMPARATORIntervention: Drug: Placebo
Interventions
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 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 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
Eligibility Criteria
You may qualify if:
- Have been diagnosed as non-constipation by ROME III.
- Patients who voluntarily signed written informed consent may participate in the study.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SK Chemicals
Seoul, South Korea
Study Officials
- STUDY CHAIR
Hyo Jin Park, M.D.
Gangnam Severance Hospital, Yonsei University College of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2014
First Posted
March 6, 2014
Study Start
January 1, 2013
Primary Completion
March 1, 2014
Study Completion
April 1, 2014
Last Updated
June 1, 2015
Record last verified: 2015-05