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

June 10, 2015 updated by: SK Chemicals Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

273

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seoul
      • Gang Nam Gu, Seoul, Korea, Republic of, 135-720
        • Gang Nam Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. more than 18 years old
  2. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Two tablets of YKP10811 placebo are administered orally once a day for 12 weeks.
Drug: YKP10811 placebo
EXPERIMENTAL: YKP10811 10mg
Two tablets of YKP10811 5mg are administered orally once a day for 12 weeks.
Drug: YKP10811 5mg
EXPERIMENTAL: YKP10811 20mg
One tablet of YKP10811 20mg and one tablet of placebo are administered orally once a day for 12 weeks.
Drug: YKP10811 placebo
Drug: YKP10811 20mg
EXPERIMENTAL: YKP10811 40mg
Two tablets of YKP10811 20mg are administered orally once a day for 12 weeks.
Drug: YKP10811 20mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
subject global assessment
Time Frame: 12 weeks
the degree of symptom relief on abdominal pain, bloating, stool frequency, stool consistency, etc.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SK Chemicals Co., Ltd.

Investigators

  • Principal Investigator: Hyo jin Park, MD.PhD., Gang Nam Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

February 10, 2014

First Submitted That Met QC Criteria

March 7, 2014

First Posted (ESTIMATE)

March 10, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

June 12, 2015

Last Update Submitted That Met QC Criteria

June 10, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YKP10811_IBS_II_2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Irritable Bowel Syndrome

Clinical Trials on YKP10811 placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe