Prospan® Hustenzäpfchen - Investigation on Efficacy and Tolerability in Children

NCT01127048 | Unknown Phase 3 DMC

• 1 other identifier: EA-08-1-34
• Study Type: interventional
• Target: 1,400
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

bronchitis; coughing; children; Ivy; Hedera helix L.

Outcome Measures

Primary Outcomes (1)

• Primary outcome measure

  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.

  7 days

Secondary Outcomes (1)

• Secondary variables

  7 days

Study Arms (2)

Prospan Hustenzäpfchen

EXPERIMENTAL

Drug: Suppositories containing Ivy leaves dry extract

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Suppositories containing Ivy leaves dry extract DRUG

Suppositories containing Ivy leaves dry extract

Also known as: Prospan® Hustenzäpfchen

Prospan Hustenzäpfchen

Placebo DRUG

Suppositories containing no Ivy leaves dry extract

Placebo

Eligibility Criteria

• Age: Up to 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• male or female children aged 0 to 6 years
• acute bronchitis existing not longer than three days and accompanied by coughing
• symptom rating score of ≥ 5 assessed by the investigator
• symptom 'frequency of coughing' of ≥ 2 assessed by the investigator
• the patient's legal representatives must give informed consent in accordance with the supposed will of the patient, after having been informed about benefits and potential risks of the trial, as well as details of the insurance taken out to cover the risk for patients participating in the study -

You may not qualify if:

• hypersensitivity to the active ingredient or to any further constituents of the pharmaceutical preparations
• patients with severe allergies or multiple drug allergies
• any other pulmonary disease within the last two weeks
• chronic pulmonary diseases
• exacerbation of chronic pulmonary disease
• suspicion of bacterial pulmonary infection
• fever above 39°C (rectal measurement) -

Sponsors & Collaborators

• Engelhard Arzneimittel GmbH & Co.KG: lead

Study Sites (1)

Engelhard Arzneimittel GmbH & Co. KG

Niederdorfelden, 61138, Germany

RECRUITING

MeSH Terms

Conditions

Bronchitis; Cough

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gerhard Zwacka, Prof. Dr.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuela Stauss-Grabo, Dr.

CONTACT

m.stauss-grabo@engelhard-am.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 3, 2010
• First Posted: May 20, 2010
• Study Start: October 1, 2008
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 15, 2011

Record last verified: 2010-05

Locations

DE (1)