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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02082457
Other study ID # YKP10811_IBS_II_2013
Secondary ID
Status Completed
Phase Phase 2
First received February 10, 2014
Last updated June 10, 2015
Start date December 2013
Est. completion date December 2014

Study information

Verified date June 2015
Source SK Chemicals Co.,Ltd.
Contact n/a
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 273
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
YKP10811 5mg

YKP10811 20mg

YKP10811 placebo


Locations

Country Name City State
Korea, Republic of Gang Nam Severance Hospital Gang Nam Gu Seoul

Sponsors (1)

Lead Sponsor Collaborator
SK Chemicals Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary subject global assessment the degree of symptom relief on abdominal pain, bloating, stool frequency, stool consistency, etc. 12 weeks No
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