Efficacy and Safety of YKP10811 in Subjects With Irritable Bowel Syndrome With Constipation
YKP
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
1 other identifier
interventional
273
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2013
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 10, 2014
CompletedFirst Posted
Study publicly available on registry
March 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJune 12, 2015
June 1, 2015
1 year
February 10, 2014
June 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
12weeks
Secondary Outcomes (1)
subject global assessment
12 weeks
Study Arms (4)
Placebo
PLACEBO COMPARATORTwo tablets of YKP10811 placebo are administered orally once a day for 12 weeks.
YKP10811 10mg
EXPERIMENTALTwo tablets of YKP10811 5mg are administered orally once a day for 12 weeks.
YKP10811 20mg
EXPERIMENTALOne tablet of YKP10811 20mg and one tablet of placebo are administered orally once a day for 12 weeks.
YKP10811 40mg
EXPERIMENTALTwo tablets of YKP10811 20mg are administered orally once a day for 12 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- more than 18 years old
- patients met with ROME III criteria for C-type IBS
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gang Nam Severance Hospital
Gang Nam Gu, Seoul, 135-720, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyo jin Park, MD.PhD.
Gang Nam Severance Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2014
First Posted
March 10, 2014
Study Start
December 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
June 12, 2015
Record last verified: 2015-06