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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02082457
Recruitment Status : Completed
First Posted : March 10, 2014
Last Update Posted : June 12, 2015
Sponsor:
Information provided by (Responsible Party):
SK Chemicals Co., Ltd.

Tracking Information
First Submitted Date  ICMJE February 10, 2014
First Posted Date  ICMJE March 10, 2014
Last Update Posted Date June 12, 2015
Study Start Date  ICMJE December 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2015)
subject global assessment [ Time Frame: 12 weeks ]
the degree of symptom relief on abdominal pain, bloating, stool frequency, stool consistency, etc.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2014)
subject global assessment [ Time Frame: 12 weeks ]
the dgree of symptom relief on abdominal pain, bloating, stool frequency, stool consitency, etc.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of YKP10811 in Subjects With Irritable Bowel Syndrome With Constipation
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Irritable Bowel Syndrome
  • Constipation
Intervention  ICMJE
  • Drug: YKP10811 5mg
  • Drug: YKP10811 20mg
  • Drug: YKP10811 placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Two tablets of YKP10811 placebo are administered orally once a day for 12 weeks.
    Intervention: Drug: YKP10811 placebo
  • Experimental: YKP10811 10mg
    Two tablets of YKP10811 5mg are administered orally once a day for 12 weeks.
    Intervention: 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.
    Interventions:
    • Drug: YKP10811 20mg
    • Drug: YKP10811 placebo
  • Experimental: YKP10811 40mg
    Two tablets of YKP10811 20mg are administered orally once a day for 12 weeks.
    Intervention: Drug: YKP10811 20mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2015)
273
Original Estimated Enrollment  ICMJE
 (submitted: March 7, 2014)
276
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02082457
Other Study ID Numbers  ICMJE YKP10811_IBS_II_2013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SK Chemicals Co., Ltd.
Study Sponsor  ICMJE SK Chemicals Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hyo jin Park, MD.PhD. Gang Nam Severance Hospital
PRS Account SK Chemicals Co., Ltd.
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP