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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.

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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Constipation Drug: YKP10811 5mg Drug: YKP10811 20mg Drug: YKP10811 placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 273 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

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 20mg
Drug: YKP10811 placebo
Experimental: YKP10811 40mg
Two tablets of YKP10811 20mg are administered orally once a day for 12 weeks.
Drug: YKP10811 20mg



Primary Outcome Measures :
  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 Outcome Measures :
  1. subject global assessment [ Time Frame: 12 weeks ]
    the degree of symptom relief on abdominal pain, bloating, stool frequency, stool consistency, etc.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082457


Locations
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Korea, Republic of
Gang Nam Severance Hospital
Gang Nam Gu, Seoul, Korea, Republic of, 135-720
Sponsors and Collaborators
SK Chemicals Co., Ltd.
Investigators
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Principal Investigator: Hyo jin Park, MD.PhD. Gang Nam Severance Hospital
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Responsible Party: SK Chemicals Co., Ltd.
ClinicalTrials.gov Identifier: NCT02082457    
Other Study ID Numbers: YKP10811_IBS_II_2013
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: June 12, 2015
Last Verified: June 2015
Keywords provided by SK Chemicals Co., Ltd.:
Irritable Bowel Syndrome
Constipation
C-IBS
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Constipation
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases