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Comparative Efficacy and Safety of Fenoverine

NCT01507922 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2014-12-18

No results posted yet for this study

Summary

It is a randomized double-blind parallel phase IV study to compare Fenoverine and Trimebutine maleate in the efficacy and safety.

Study Hypothesis: Fenoverine is non-inferior to Trimebutine maleate in its efficacy and safety.

Conditions

  • Irritable Bowel Syndrome

Interventions

DRUG

Fenoverine

Fenoverine 100mg three times a day for 8 weeks

DRUG

Timebutine

Timebutine maleate 150mg three times a day for 8 weeks

Sponsors & Collaborators

  • Bukwang Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • Yoon Tae Jeen, Dr. · Korea University Anam Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-03-31
Completion
2013-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01507922 on ClinicalTrials.gov