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

Irritable Bowel Syndrome Clinical Trial

— YKP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02082457
• Other study ID #: YKP10811_IBS_II_2013
• 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

• Constipation
• Irritable Bowel Syndrome
• Syndrome

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