Treatment of Patients Suffering From Nervous Restlessness With PASCOFLAIR®
Nyckelord
Abstrakt
Beskrivning
The study was carried out as a prospective, non-interventional study with the intention of subsequent process cost analyses (PCA) and also considers quality of life, drug misuse, dependence, adverse events and therapy satisfaction. Data were collected in collaboration with 22 physicians in Germany.
The study was designed as a one armed non-interventional study. Patients had to suffer from nervous restlessness in order to be eligible for study documentation. Participants agreed to a medical treatment with PASCOFLAIR® of 12 weeks. In this context, documented patients could take PASCOFLAIR® at the first time or could have started within the past three months before the initial visit. Furthermore, documented patients had to be older than 18 years and must be able to read and understand the patient declaration of data protection and the declaration of consent. The patient must not be an alcoholic, must not be drug dependent and have no other types of addiction. Patients who were pregnant or breast-feeding were not eligible for study participation. Furthermore, patients showing hypersensitivity against passionflower extract or against other components of the medication were excluded. The signed declaration of consent of participating patients is available.
The treatment of affected patients may not be documented, if a redemption (written or spoken) of the declaration of consent is existing or the patient takes Benzodiazepines.
Datum
| Senast verifierad: | 03/31/2017 |
| Först skickat: | 01/05/2016 |
| Beräknad anmälan inlämnad: | 01/07/2016 |
| Först publicerad: | 01/10/2016 |
| Senaste uppdatering skickad: | 04/03/2017 |
| Senaste uppdatering publicerad: | 06/18/2017 |
| Datum för första inlämnade resultat: | 04/20/2016 |
| Datum för första inlämnade QC-resultat: | 04/03/2017 |
| Datum för först publicerade resultat: | 06/18/2017 |
| Faktiskt startdatum för studien: | 08/31/2014 |
| Uppskattat primärt slutdatum: | 05/31/2015 |
| Beräknat slutfört datum: | 05/31/2015 |
Tillstånd eller sjukdom
Fas
Urvalskriterier
| Åldrar berättigade till studier | 18 Years Till 18 Years |
| Kön som är berättigade till studier | All |
| Testmetod | Probability Sample |
| Accepterar friska volontärer | Ja |
| Kriterier | Inclusion Criteria: - patients suffering from nervous restlessness Exclusion Criteria: - Age < 18 years and must be able to read and understand the patient declaration of data protection and the declaration of consent - alcoholics, drug pending, addictive disorder - pregnancy or lactating - patients showing hypersensitivity against passionflower extract or against other components of the medication |
Resultat
Primära resultatåtgärder
1. Change of Symptom Inner Restlessness (Pre - Post) [Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)]
Sekundära resultatåtgärder
1. Change of Symptom Sleep Disturbance (Pre - Post) [Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)]
2. Change of Symptom Exhaustion (Pre - Post) [Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)]
3. Change of Symptom Fear (Pre - Post) [Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)]
4. Change of Symptom Lack of Concentration (Pre - Post) [Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)]
5. Change of Symptom Transpiration (Pre - Post) [Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline )]
6. Change of Symptom Nausea (Pre - Post) [Change from Baseline (before treatment; week 0) to last visit (end of observation-approx. 12 weeks after baseline)]
7. Change of Symptom Trembling (Pre - Post) [Change from Baseline (before treatment; week 0) to last visit (end of observation - approx. 12 weeks after baseline)]
8. Change of Symptom Palpation (Pre - Post) [Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)]
9. Change of BDEPQ (Benzodiazepine Dependence Questionnaire) [Change from visit 2 (approx. 4 weeks after baseline) to last visit (end of observation- approx. 12 weeks after baseline)]
10. Change of RS-13 (Resilience Questionnaire) (Pre - Post) [Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)]
11. Change in EQ-5D (Health Questionnaire) Scores (Pre - Post) [Change from Baseline (before treatment) to last visit (end of observation- approx. 12 weeks after baseline)]
12. Change of EQ-5D VAS Scores (Pre - Post) [Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)]
13. Tolerability Assess Using a 5 Point Scale [Evaluation of Tolerability on visit 3 (appr. 12 weeks after baseline)]
