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Completed

NCT Number: NCT02079675

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

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.

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Key information

Conditions

Non-constipation Irritable Bowel Syndrome

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

SK Chemicals

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SKI3246 Low Dose

Drug

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

Drug

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

Drug

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 outcomes

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

    Time frame: 12 weeks

Secondary outcomes

  1. Patient satisfaction using 5- Likert Scale

    Time frame: 4 weeks

  2. Subject Self Reported Adequate Relief of Pain

    Time frame: 4 weeks

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

    Time frame: 12 weeks

  4. Visual Analog Scale (VAS)

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

SK Chemicals Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 6, 2014
Registry last updated
Jun 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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