Prospan® Hustenzäpfchen - Investigation on Efficacy and Tolerability in Children
Recruitment status was: Recruiting
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.
|Symptoms of Acute Bronchitis Accompanied by Coughing||Drug: Suppositories containing Ivy leaves dry extract Drug: Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Investigation on Efficacy and Tolerability of Prospan® Hustenzäpfchen for the Symptomatic Treatment of Acute Bronchitis Accompanied by Coughing in Children|
- Primary outcome measure [ Time Frame: 7 days ]
Effect of treatment as primary variable will be assessed by comparing baseline values to those obtained during visit 2.
The primary outcome measure for efficacy will be the relative change in the symptom score between visits 1 and 2.
- Secondary variables [ Time Frame: 7 days ]
- absolute change of total symptom score
- time to response
- compliance, defined by drug accountability
- percentage of patients requiring concomitant medication for treatment of cough
- rates of premature withdrawal
- incidence of Adverse Events
|Study Start Date:||October 2008|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
|Experimental: Prospan Hustenzäpfchen||
Drug: Suppositories containing Ivy leaves dry extract
Suppositories containing Ivy leaves dry extract
Other Name: Prospan® Hustenzäpfchen
|Placebo Comparator: Placebo||
Suppositories containing no Ivy leaves dry extract
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01127048
|Contact: Manuela Stauss-Grabo, Dr.||firstname.lastname@example.org|
|Engelhard Arzneimittel GmbH & Co. KG||Recruiting|
|Niederdorfelden, Germany, 61138|
|Contact: Manuela Stauss-Grabo, Dr.|
|Principal Investigator:||Gerhard Zwacka, Prof. Dr.|