PASCONAL NERVENTROPFEN in the Treatment of Nervous Diseases (174)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pascoe Pharmazeutische Praeparate GmbH
ClinicalTrials.gov Identifier:
NCT01125605
First received: May 10, 2010
Last updated: August 27, 2012
Last verified: August 2012
  Purpose

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).


Condition
Nervousness
Sleep Disorders

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PASCONAL NERVENTROPFEN in the Treatment of Adults and Children Suffering From Nervous Diseases (e.g. Sleep Disorders Due to Nervousness)

Resource links provided by NLM:


Further study details as provided by Pascoe Pharmazeutische Praeparate GmbH:

Primary Outcome Measures:
  • Sumscore of 12 Individual Symptoms for Visit 1 (Baseline), Visit 2, and Visit 3 [ Time Frame: begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3) ] [ Designated as safety issue: No ]
    The severity of 12 symptoms (nervousness/restlessness, irritability/eccentricity, sleep disorders, fitful sleep, hyperactivity, nocturnal activity, lack of concentration/forgetfulness, tiredness, discontent, listlessness, gastrointestinal problems, and headache/pressure) was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints) and for the sum score of all 12 individual symptom scores (0 (no complaints) - 36 (all strong complaints).

  • Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation [ Time Frame: begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3) ] [ Designated as safety issue: No ]
    The severity of nervousness/restlessness was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints).

  • Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation [ Time Frame: begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3) ] [ Designated as safety issue: No ]
    The severity of irritability/eccentricity was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints).

  • Tolerability After Visit 2 and Visit 3 [ Time Frame: appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3) ] [ Designated as safety issue: No ]
    Assessment of tolerability at visit 2 and visit 3 well tolerated = no side effcts poor tolerated = side effects


Secondary Outcome Measures:
  • Changes of the Sum Score Between Baseline and Last Observation by Concomitant Medication and Treatment Duration [ Time Frame: begin (visit 1) and last obvservation (could be appr. after 2 weeks (visit 2) or 4 weeks (visit 3)) ] [ Designated as safety issue: No ]

    The severity of 12 symptoms (nervousness/restlessness, irritability/eccentricity, sleep disorders, fitful sleep, hyperactivity, nocturnal activity, lack of concentration/forgetfulness, tiredness, discontent, listlessness, gastrointestinal problems, and headache/pressure) was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints) and for the sum score of all 12 individual symptom scores (0 (no complaints) - 36 (all strong complaints).

    Decrease of the sumscore between baseline and last observation by concomitant medication (with and withour medication) and treatment duration (< 4 weeks and >= 4 weeks)


  • Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Concomitant Medication [ Time Frame: begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3)) ] [ Designated as safety issue: No ]
    The symptom nervousness/restlessnesswas analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories "improved", "unchanged" and "worsened". For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was > 0).

  • Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Duration of Treatment [ Time Frame: begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3)) ] [ Designated as safety issue: No ]
    The symptom nervousness/restlessness was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories "improved", "unchanged" and "worsened". For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was > 0).

  • Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Concomitant Medication [ Time Frame: begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3)) ] [ Designated as safety issue: No ]
    The symptom irritability/eccentricity was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories "improved", "unchanged" and "worsened". For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was > 0).

  • Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Duration of Treatment [ Time Frame: begin (visit 1) and last observation (appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3)) ] [ Designated as safety issue: No ]
    The symptom irritability/eccentricity was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories "improved", "unchanged" and "worsened". For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was > 0).

  • Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Concomitant Medication (Yes/no) [ Time Frame: appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3) ] [ Designated as safety issue: No ]

    Efficacy of the therapy with PASCONAL® NERVENTROPFEN was rated by the physician on a 4-point rating scale at Visit 2 and Visit 3. The same scale was applied at Visit 1 for evaluation of the efficacy of the previous medication.

    The last evaluation for PASCONAL® NERVENTROPFEN (Visit 2 or Visit 3, according to the LOCF principle) was compared with the rating for the previous therapy by means of the categories "PASCONAL® better", "No difference" and "PASCONAL® worse".


  • Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Treatment Duration [ Time Frame: appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3) ] [ Designated as safety issue: No ]

    Efficacy of the therapy with PASCONAL® NERVENTROPFEN was rated by the physician on a 4-point rating scale at Visit 2 and Visit 3. The same scale was applied at Visit 1 for evaluation of the efficacy of the previous medication.

    The last evaluation for PASCONAL® NERVENTROPFEN (Visit 2 or Visit 3, according to the LOCF principle) was compared with the rating for the previous therapy by means of the categories "PASCONAL® better", "No difference" and "PASCONAL® worse".



Enrollment: 325
Study Start Date: May 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adults > 12 years
Children 6-12 years
Children 1-6 years

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Observational groups

Patients (adults and children 1-12 years of age) suffering from nervous diseases, e.g. sleep-disturbances due to nervousness.

Criteria

Due to the design as an Observational Study no inclusion or exclusion criteria are named. The included patient group is described under "Cohort / Group".

Observational Criteria:

  • Males and females
  • Children 1-12 years old
  • Adults >12 years old
  • suffering from nervous diseases,
  • e.g. sleep disorders due to nervousness.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125605

Locations
Germany
Multiple German Practices
all over Germany, Germany
Sponsors and Collaborators
Pascoe Pharmazeutische Praeparate GmbH
Investigators
Study Director: Bianka Krick Pascoe Pharmazeutische Praeparate GmbH
  More Information

No publications provided

Responsible Party: Pascoe Pharmazeutische Praeparate GmbH
ClinicalTrials.gov Identifier: NCT01125605     History of Changes
Other Study ID Numbers: 174A10PNAL
Study First Received: May 10, 2010
Results First Received: July 18, 2012
Last Updated: August 27, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Pascoe Pharmazeutische Praeparate GmbH:
PASCONAL
nervousness
nervosity
sleep disorder

Additional relevant MeSH terms:
Sleep Disorders
Parasomnias
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on August 20, 2014