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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

273 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Irritable Bowel Syndrome Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Two tablets of YKP10811 placebo are administered orally once a day for 12 weeks.

Group Type PLACEBO_COMPARATOR

YKP10811 placebo

Intervention Type DRUG

YKP10811 10mg

Two tablets of YKP10811 5mg are administered orally once a day for 12 weeks.

Group Type EXPERIMENTAL

YKP10811 5mg

Intervention Type DRUG

YKP10811 20mg

One tablet of YKP10811 20mg and one tablet of placebo are administered orally once a day for 12 weeks.

Group Type EXPERIMENTAL

YKP10811 20mg

Intervention Type DRUG

YKP10811 placebo

Intervention Type DRUG

YKP10811 40mg

Two tablets of YKP10811 20mg are administered orally once a day for 12 weeks.

Group Type EXPERIMENTAL

YKP10811 20mg

Intervention Type DRUG

Interventions

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YKP10811 5mg

Intervention Type DRUG

YKP10811 20mg

Intervention Type DRUG

YKP10811 placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No