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

Phase 2CompletedNCT02082457

SK Chemicals Co., Ltd.273 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

273

Conditions

Irritable Bowel Syndrome Constipation

Interventions

YKP10811 5mgDRUG

YKP10811 20mgDRUG

YKP10811 placeboDRUG

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Gang Nam Severance Hospital

Gang Nam Gu, Seoul, South Korea

Outcomes

Primary Outcomes

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

Time frame: 12weeks

Secondary Outcomes

subject global assessment

the degree of symptom relief on abdominal pain, bloating, stool frequency, stool consistency, etc.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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