PASCONAL NERVENTROPFEN in the Treatment of Nervous Diseases

NCT ID: NCT01125605

Last Updated: 2015-04-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

325 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-10-31

Brief Summary

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The purpose of this observational study is to give an overview of the use of PASCONAL NERVENTROPFEN in a 2-4 week treatment of nervous diseases, especially sleep disorders due to nervousness.

Detailed Description

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The purpose of this observational study is to give an overview of the use of PASCONAL NERVENTROPFEN in a 2-4 week treatment of nervous diseases, especially sleep disorders due to nervousness.

Efficacy and tolerability of the drug will be assessed. Special regard will be taken to the administration management, dose regimen, and to the effectiveness and safety in special patient groups (children 1-12 years of age), in relation to treatment conformity to the Summary of Product Characteristics (SmPC).

Conditions

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Nervousness Sleep Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adults > 12 years

adult patients and patients older than 12 years

No interventions assigned to this group

Children 6-12 years

children between 6 and 12 years

No interventions assigned to this group

Children 1-6 years

children between 1 and 6 years

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Males and females
* Children 1-12 years old
* Adults \>12 years old
* suffering from nervous diseases, e.g. sleep disorders due to nervousness.

Exclusion Criteria

* children younger than 1 year
* no nervous diseases, e.g. sleep disorders due to nervousness.
* no treatment with PASCONAL NERVENTROPFEN
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pascoe Pharmazeutische Praeparate GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bianka Krick

Role: STUDY_DIRECTOR

Pascoe Pharmazeutische Praeparate GmbH

Locations

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Multiple German Practices

All Over Germany, , Germany

Site Status

Countries

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Germany

Other Identifiers

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174A10PNAL

Identifier Type: -

Identifier Source: org_study_id

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