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Completed

NCT Number: NCT02082457

Efficacy and Safety of YKP10811 in Subjects With Irritable Bowel Syndrome With Constipation

This trial is to investigate efficacy and safety of YKP10811 in Subjects With Irritable Bowel Syndrome With Constipation. The difference of responder rate between test group (10, 20 and 40mg) and placebo will be evaluated.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Constipation Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Gang Nam Severance Hospital

Gang Nam Gu, Seoul, 135-720, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • more than 18 years old
  • patients met with ROME III criteria for C-type IBS

Exclusion criteria

  • pregnancy or lactation
  • a history of surgery for gastrointestinal tract
  • a history of gastrointestinal bleeding, diverticulitis and ileus within 1 year of screening visit
  • inflammatory bowel disease or malignant tumor within 5 years of screening visit
  • taking drugs that could have impact on efficacy assessment

Treatment and study plan

YKP10811 5mg

Drug

YKP10811 20mg

Drug

YKP10811 placebo

Drug

Primary outcomes

  1. Abdominal pain intensity & stool frequency responder

    Time frame: 12weeks

    an improvement of equl and more than 30% from baseline in the average of the daily worst abdominal pain score and an increase of equal and more than 1 CSBM from baseline

Secondary outcomes

  1. subject global assessment

    Time frame: 12 weeks

    the degree of symptom relief on abdominal pain, bloating, stool frequency, stool consistency, etc.

Sponsors and collaborators

Lead sponsor

SK Chemicals Co., Ltd.

Industry

Registry information

Official study title

Multi-center, Randomized, Double Blinded, Placebo-controlled, Phase II Trial to Assess the Efficacy and Safety of YKP10811 in Subjects With Irritable Bowel Syndrome With Constipation

Acronym: YKP

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 10, 2014
Registry last updated
Jun 12, 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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