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

Primary Purpose

Irritable Bowel Syndrome, Constipation

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
YKP10811 5mg
YKP10811 20mg
YKP10811 placebo
Sponsored by
SK Chemicals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome, Constipation, C-IBS

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gang Nam Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

YKP10811 10mg

YKP10811 20mg

YKP10811 40mg

Arm Description

Two tablets of YKP10811 placebo are administered orally once a day for 12 weeks.

Two tablets of YKP10811 5mg are administered orally once a day for 12 weeks.

One tablet of YKP10811 20mg and one tablet of placebo are administered orally once a day for 12 weeks.

Two tablets of YKP10811 20mg are administered orally once a day for 12 weeks.

Outcomes

Primary Outcome Measures

Abdominal pain intensity & stool frequency responder
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 Outcome Measures

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

Full Information

First Posted
February 10, 2014
Last Updated
June 10, 2015
Sponsor
SK Chemicals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02082457
Brief Title
Efficacy and Safety of YKP10811 in Subjects With Irritable Bowel Syndrome With Constipation
Acronym
YKP
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SK Chemicals Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Constipation
Keywords
Irritable Bowel Syndrome, Constipation, C-IBS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
273 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Two tablets of YKP10811 placebo are administered orally once a day for 12 weeks.
Arm Title
YKP10811 10mg
Arm Type
Experimental
Arm Description
Two tablets of YKP10811 5mg are administered orally once a day for 12 weeks.
Arm Title
YKP10811 20mg
Arm Type
Experimental
Arm Description
One tablet of YKP10811 20mg and one tablet of placebo are administered orally once a day for 12 weeks.
Arm Title
YKP10811 40mg
Arm Type
Experimental
Arm Description
Two tablets of YKP10811 20mg are administered orally once a day for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
YKP10811 5mg
Intervention Type
Drug
Intervention Name(s)
YKP10811 20mg
Intervention Type
Drug
Intervention Name(s)
YKP10811 placebo
Primary Outcome Measure Information:
Title
Abdominal pain intensity & stool frequency responder
Description
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
Time Frame
12weeks
Secondary Outcome Measure Information:
Title
subject global assessment
Description
the degree of symptom relief on abdominal pain, bloating, stool frequency, stool consistency, etc.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyo jin Park, MD.PhD.
Organizational Affiliation
Gang Nam Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gang Nam Severance Hospital
City
Gang Nam Gu
State/Province
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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