NCT02079675

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 279 (actual)
• Sponsor: SK Chemicals Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-constipation Irritable Bowel Syndrome

Interventions

Type	Name	Description
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
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
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

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-03-01
• Completion: 2014-04-01
• First posted: 2014-03-06
• Last updated: 2015-06-01

Locations

1 site across 1 country: South Korea