Constipation, Irritable Bowel Syndrome
Conditions
Keywords
Irritable Bowel Syndrome, Constipation, C-IBS
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.
Interventions
DRUGYKP10811 5mg
DRUGYKP10811 20mg
DRUGYKP10811 placebo
Sponsors
SK Chemicals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abdominal pain intensity & stool frequency responder | 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
| Measure | Time frame | Description |
|---|---|---|
| subject global assessment | 12 weeks | the degree of symptom relief on abdominal pain, bloating, stool frequency, stool consistency, etc. |
Countries
South Korea
Outcome results
None listed