PASCONAL NERVENTROPFEN in the Treatment of Nervous Diseases (174)
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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) |
- 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
- 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 |
Observational groups
Patients (adults and children 1-12 years of age) suffering from nervous diseases, e.g. sleep-disturbances due to nervousness.
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 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 May 23, 2013