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

SK chemicals

Status and phase: Completed; Phase 2

Conditions: Irritable Bowel Syndrome; Constipation

Treatments: Drug: YKP10811 20mg; Drug: YKP10811 placebo; Drug: YKP10811 5mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02082457

YKP10811_IBS_II_2013

Details and patient eligibility

About

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.

Enrollment: 273 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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273 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: YKP10811 placebo

YKP10811 10mg

Experimental group

Description:

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

Treatment:

Drug: YKP10811 5mg

YKP10811 20mg

Experimental group

Description:

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

Treatment:

Drug: YKP10811 placebo

Drug: YKP10811 20mg

YKP10811 40mg

Experimental group

Description:

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

Treatment:

Drug: YKP10811 20mg