Prospan® Hustenzäpfchen - Investigation on Efficacy and T... | NCT01127048

Studies
Prospan® Hustenzäpfchen - Investigation on Efficacy and Tolerability in Children

NCT01127048

Sponsor

Engelhard Arzneimittel GmbH & Co.KG

Status

Unknown status

Last Update Posted

Jun 15, 2011Estimated

Enrollment

1,400Estimated

Phase

Phase 3

Conditions

Symptoms of Acute Bronchitis Accompanied by Coughing

Interventions

Suppositories containing Ivy leaves dry extract
Placebo

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Aug 2013Estimated

Completion Date

Aug 2013Estimated

First Submitted Date

May 3, 2010

First Submission Date that Met QC Criteria

May 19, 2010

First Posted Date

May 20, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2011

Last Update Posted Date

Jun 15, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prospan Hustenzäpfchen	Experimental		Drug: Suppositories containing Ivy leaves dry extract
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Suppositories containing Ivy leaves dry extract	Drug	Suppositories containing Ivy leaves dry extract	Prospan Hustenzäpfchen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Secondary variables	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	7 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 -

Exclusion Criteria:

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) -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Manuela Stauss-Grabo, Dr.	Contact			m.stauss-grabo@engelhard-am.de

Overall Officials

Name	Affiliation	Role
Gerhard Zwacka, Prof. Dr.		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Engelhard Arzneimittel GmbH & Co. KG	Recruiting	Niederdorfelden		61138	Germany

Condition Browse Module

MeSH Terms

ID	Term
D001991	Bronchitis
D003371	Cough

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases

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