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Efficacy/Safety Study to Confirm Iberogast's Efficacy in Patients With Irritable Bowel Syndrome Diagnosed on ROME III Criteria Compared to Placebo

NCT01940848 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2018-10-29

No results posted yet for this study

Summary

The study shall prove whether treatment of irritable bowel syndrome with Iberogast is superior to placebo regarding the main criterium "pain"

Conditions

  • Irritable Bowel Syndrome

Interventions

DRUG

STW5 (Iberogast, BAY98-7411)

Applied orally over 28 days, 20 drops STW 5 three times daily

DRUG

Placebo

Applied orally over 28 days, 20 drops placebo three times daily

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-11
Primary Completion
2017-10-25
Completion
2017-10-25

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT01940848 on ClinicalTrials.gov