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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults > 12 years | adult patients and patients older than 12 years | ||
| Children 6-12 years | children between 6 and 12 years | ||
| Children 1-6 years | children between 1 and 6 years |
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| Measure | Description | Time Frame |
|---|---|---|
| Sumscore of 12 Individual Symptoms for Visit 1 (Baseline), Visit 2, and Visit 3 | 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). | begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3) |
| Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation | The severity of nervousness/restlessness was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints). | begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3) |
| Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation | The severity of irritability/eccentricity was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints). | begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3) |
| Tolerability After Visit 2 and Visit 3 | Assessment of tolerability at visit 2 and visit 3 well tolerated = no side effcts poor tolerated = side effects | appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of the Sum Score Between Baseline and Last Observation by Concomitant Medication and Treatment Duration | 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) |
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Due to the design as an Observational Study no inclusion or exclusion criteria for therapy are named. The included patient group is described under "Cohort / Group".
Observational Criteria (=inclusion criteria for documentation):
Exclusion criteria for documentation:
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Observational groups
Patients (adults and children 1-12 years of age) suffering from nervous diseases, e.g. sleep-disturbances due to nervousness.
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| Name | Affiliation | Role |
|---|---|---|
| Bianka Krick | Pascoe Pharmazeutische Praeparate GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple German Practices | All Over Germany | Germany |
It was an non-inteventional observational study with 3 visits.
Physicians who were registered in the past with the treatment focus on central nervous system / psyche. The recruitment of the participating physicians was done by the field service of PASCOE.
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| ID | Title | Description |
|---|---|---|
| FG000 | Observational Group | Pasconal Nerventropfen PASCONAL® NERVENTROPFEN is a homoeopathic combination product (oral drops) consisting out of 4 ingredients: Avena sativa, Valeriana, Ignatia and Tarantula. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Observational Group | Pasconal Nerventropfen |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sumscore of 12 Individual Symptoms for Visit 1 (Baseline), Visit 2, and Visit 3 | 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). | descriptive; for all partcipations with values at the visits | Posted | Mean | Standard Deviation | units on a scale | begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3) |
|
after appr. 2 weeks and after appr. 4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Observational Group | Pasconal Nerventropfen |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gastrointestinal | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Pascoe pharmazeutische Praeparate GmbH | 0049 641 7960100 | klinische.forschung@pascoe.de |
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| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| begin (visit 1) and last obvservation (could be appr. after 2 weeks (visit 2) or 4 weeks (visit 3)) |
| Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Concomitant Medication | 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). | begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3)) |
| Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Duration of Treatment | 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). | begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3)) |
| Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Concomitant Medication | 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). | begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3)) |
| Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Duration of Treatment | 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). | begin (visit 1) and last observation (appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3)) |
| Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Concomitant Medication (Yes/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". | appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3) |
| Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Treatment Duration | 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". | appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3) |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Concomitant medication | Number | participants |
|
| Duration of disease years | Mean | Standard Deviation | years |
|
| State of inclusion diagnosis | The duration of complaints was divided into two groups to the extent this was possible:
| Number | participants |
|
| Previous treatment of inclusion diagnosis | Within the range of the observational study, it was ascertained whether the inclusion diagnosis had been treated previously. | Number | participants |
|
| OG001 |
| Visit 2 |
Observational group (Pasconal Nerventropfen) at visit 2 |
| OG002 | Visit 3 | Observational group (Pasconal Nerventropfen) at visit 3 |
| OG003 | Last Observation | Observational group (Pasconal Nerventropfen) at last observation |
|
|
| Secondary | Changes of the Sum Score Between Baseline and Last Observation by Concomitant Medication and Treatment Duration | 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) | exploratively, all participations with values | Posted | Mean | Standard Deviation | units on a scale | begin (visit 1) and last obvservation (could be appr. after 2 weeks (visit 2) or 4 weeks (visit 3)) |
|
|
|
|
| Secondary | Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Concomitant Medication | 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). | exploratively, all participations with values | Posted | Number | participants | begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3)) |
|
|
|
|
| Secondary | Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Duration of Treatment | 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). | exploratively, all participations with values | Posted | Number | participants | begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3)) |
|
|
|
|
| Secondary | Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Concomitant Medication | 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). | exploratively, all participations with values | Posted | Number | participants | begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3)) |
|
|
|
|
| Secondary | Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Duration of Treatment | 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). | exploratively, all participations with values | Posted | Number | participants | begin (visit 1) and last observation (appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3)) |
|
|
|
|
| Secondary | Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Concomitant Medication (Yes/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". | exploratively, all participations with values | Posted | Number | participants | appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3) |
|
|
|
|
| Primary | Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation | The severity of nervousness/restlessness was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints). | descriptive; for all partcipations with values at the visits | Posted | Number | participants | begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3) |
|
|
|
| Secondary | Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Treatment Duration | 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". | exploratively, all participations with values | Posted | Number | participants | appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3) |
|
|
|
|
| Primary | Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation | The severity of irritability/eccentricity was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints). | descriptive; for all partcipations with values at the visits | Posted | Number | participants | begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3) |
|
|
|
| Primary | Tolerability After Visit 2 and Visit 3 | Assessment of tolerability at visit 2 and visit 3 well tolerated = no side effcts poor tolerated = side effects | descriptive; for safety 326 patients were analysed; 1 patient had no efficacy values and were not analysed for efficacy; so a discrepancy between 325 patients (for efficacy) and 326 (for safety) occured | Posted | Number | participants | appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3) |
|
|
|
| 0 |
| 326 |
| 14 |
| 326 |
| nausea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| tiredness | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| headache | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| tachycardia | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
|
| heartburn | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| aggressivity | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
|
| stomach ache | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| tongue and mucosa under tongue | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
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| D001523 | Mental Disorders |
| < 4 weeks treatment duration |
|
| >= 4 weeks treatment duration |
|
decrease of the sum score between baseline (visit1) and last observation by duration of treatment |
| ANCOVA |
ANCOVA with GLM (Generalized Linear Model) of SAS® (with type III sums of squares); including the baseline value of the sum score as a covariate |
| 0.0002 |
| 95 |
| No |
| Superiority or Other |
| worsened |
|
| worsened |
|
| worsened |
|
| worsened |
|
| PACONAL worse |
|
| 1=mild |
|
| 2=moderate |
|
| 3=Strong |
|
| PACONAL worse |
|
| 1=mild |
|
| 2=moderate |
|
| 3=Strong |
|