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Prospan® Hustenzäpfchen - Investigation on Efficacy and Tolerability in Children

2014-08-27 03:13:33 | BioPortfolio

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.

Description

After interim analysis of the first part the clinical study will be continued as follows: Double blind, placebo controlled, randomised, multi-centre study with 2-parallel groups for the treatment of acute bronchitis accompanied by coughing in children aged 0 - 6 years to demonstrate efficacy and safety of Prospan® Hustenzäpfchen.

For assessment of cough intensity and severity a specific symptom score has been developed, which gathers the child's frequency and severity of coughing and of cough productivity as well as the severity of rhonchi (each symptom will be assessed on a four-point Likert scale ranging from 0 to 3; total score range: 0-12 points).

Considering the specificities of the study population and the disease, confirmatory evaluation will be based on the change in the symptom score after the first three consecutive days of treatment as assessed by the investigator.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Symptoms of Acute Bronchitis Accompanied by Coughing

Intervention

Suppositories containing Ivy leaves dry extract, Placebo

Location

Engelhard Arzneimittel GmbH & Co. KG
Niederdorfelden
Germany
61138

Status

Recruiting

Source

Engelhard Arzneimittel GmbH & Co.KG

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:33-0400

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