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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02079675

Enrollment

279

Registered

2014-03-06

Start date

2013-01-31

Completion date

2014-04-30

Last updated

2015-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-constipation Irritable Bowel Syndrome

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.

Interventions

DRUGSKI3246 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

DRUGSKI3246 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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026