MedTrace Logo

Prospan® Hustenzäpfchen - Investigation on Efficacy and Tolerability in Children

NCT01127048 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1400

Last updated 2011-06-15

No results posted yet for this study

Summary

The aims of this study are

* Demonstrating superior efficacy of Prospan® Hustenzäpfchen compared to Placebo in children suffering from acute bronchitis accompanied by coughing
* Characterisation of safety and tolerability of Prospan® Hustenzäpfchen in comparison with placebo.

Conditions

  • Symptoms of Acute Bronchitis Accompanied by Coughing

Interventions

DRUG

Suppositories containing Ivy leaves dry extract

Suppositories containing Ivy leaves dry extract

DRUG

Placebo

Suppositories containing no Ivy leaves dry extract

Sponsors & Collaborators

  • Engelhard Arzneimittel GmbH & Co.KG

    lead INDUSTRY

Principal Investigators

  • Gerhard Zwacka, Prof. Dr.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

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 NCT01127048 on ClinicalTrials.gov