Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Institut für Empirische Gesundheitsökonomie, Prof. Dr. Dr.med. Reinhard Rychlik,Am Ziegelfeld 28,51399 Burscheid,Germany | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Change of Symptom Inner Restlessness (Pre - Post) | Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms" | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Symptom Sleep Disturbance (Pre - Post) | Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms" | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) |
| Change of Symptom Exhaustion (Pre - Post) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients had to suffer from nervous restlessness in order to be eligible for study documentation.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PASCOFLAIR Group (Verum) | Patients who were treated with PASCOFLAIR |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 156 patients participated in the study. Two patients were excluded from the analysis, because they received Benzodiazepines (Tavor, Lexostad). One patient was 17 years of age when documented in the study. The overall study population considered in the analyses was 154 patients.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PASCOFLAIR Group (Verum) | Patients who were treated with PASCOFLAIR |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 2 missinig data |
| 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 | Change of Symptom Inner Restlessness (Pre - Post) | Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms" | If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent. Only 146 patients showed this symptom. | Posted | Number | participants | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) |
|
|
The observational period was from September 2014 till June 2015. Per Patient were adrs collected for the treatment period (12 weeks).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PASCOFLAIR Group (Verum) | Patients who were treated with PASCOFLAIR |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Inga Trompetter and Jennifer Lebert | PASCOE Pharmazeutische Präparate GmbH | 0049-(0)641-7960-955 | Jennifer.lebert@pascoe.de |
Not provided
Not provided
Not provided
Not provided
Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms" |
| Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) |
| Change of Symptom Fear (Pre - Post) | Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms" | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) |
| Change of Symptom Lack of Concentration (Pre - Post) | Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms" | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) |
| Change of Symptom Transpiration (Pre - Post) | Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms" | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline ) |
| Change of Symptom Nausea (Pre - Post) | Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms" | Change from Baseline (before treatment; week 0) to last visit (end of observation-approx. 12 weeks after baseline) |
| Change of Symptom Trembling (Pre - Post) | Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms" | Change from Baseline (before treatment; week 0) to last visit (end of observation - approx. 12 weeks after baseline) |
| Change of Symptom Palpation (Pre - Post) | Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms" | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) |
| Change of BDEPQ (Benzodiazepine Dependence Questionnaire) | The Benzodiazepine Dependence Questionnaire (BDEPQ) is a 30 item self report questionnaire designed to measure dependence on benzodiazepine tranquilisers, sedatives and hypnotics. Items cover all aspects of the dependence syndrome with the exception of withdrawal symptoms. Each item is rated on a four point likert scale referring to experiences in the last month. BDEPQ score ranges from 0 (no dependence) to 85 (most severe dependence). | Change from visit 2 (approx. 4 weeks after baseline) to last visit (end of observation- approx. 12 weeks after baseline) |
| Change of RS-13 (Resilience Questionnaire) (Pre - Post) | RS-13 is a 13 items self Report questionnaire measure the resilience, which applies a reliance scale ranging from 13 (lowest stress resistance) to 91 (highest stress resistance). | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) |
| Change in EQ-5D (Health Questionnaire) Scores (Pre - Post) | EQ-5Dâ„¢ is a standardised instrument for use as a measure of health Outcome The EQ-5D assesses five aspects of QoL: mobility, self-care, usual activity, pain/discomfort and anxiety/depression. An EQ-5D profile score of 0 points represents the worst QoL (death), while 1 point stands for full health. Data analysis was performed according to the EuroQol manual. The EQ-VAS ranges from 0 (worst QoL) to 100 (best QoL). | Change from Baseline (before treatment) to last visit (end of observation- approx. 12 weeks after baseline) |
| Change of EQ-5D VAS Scores (Pre - Post) | VAS values (Quality of Life) range from 0 (very poor) to 100 (best possible state). | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) |
| Tolerability Assess Using a 5 Point Scale | Assessment of tolerability using a 5 point scale (very good, good, satisfactory, bad, very bad) | Evaluation of Tolerability on visit 3 (appr. 12 weeks after baseline) |
| participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex/Gender, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Change of Symptom Sleep Disturbance (Pre - Post) | Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms" | If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent. Only 146 patients showed this symptom. | Posted | Number | participants | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) |
|
|
|
| Secondary | Change of Symptom Exhaustion (Pre - Post) | Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms" | If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent. Only 145 patients showed this symptom. | Posted | Number | participants | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) |
|
|
|
| Secondary | Change of Symptom Fear (Pre - Post) | Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms" | If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent. Only 133 patients showed this symptom. | Posted | Number | participants | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) |
|
|
|
| Secondary | Change of Symptom Lack of Concentration (Pre - Post) | Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms" | If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent. Only 142 patients showed this symptom. | Posted | Number | participants | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) |
|
|
|
| Secondary | Change of Symptom Transpiration (Pre - Post) | Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms" | If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent. Only 121 patients showed this symptom. | Posted | Number | participants | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline ) |
|
|
|
| Secondary | Change of Symptom Nausea (Pre - Post) | Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms" | If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent. Only 92 patients showed this symptom. | Posted | Number | participants | Change from Baseline (before treatment; week 0) to last visit (end of observation-approx. 12 weeks after baseline) |
|
|
|
| Secondary | Change of Symptom Trembling (Pre - Post) | Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms" | If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent. Only 108 patients showed this symptom. | Posted | Number | participants | Change from Baseline (before treatment; week 0) to last visit (end of observation - approx. 12 weeks after baseline) |
|
|
|
| Secondary | Change of Symptom Palpation (Pre - Post) | Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms" | If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent. Only 130 patients showed this symptom. | Posted | Number | participants | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) |
|
|
|
| Secondary | Change of BDEPQ (Benzodiazepine Dependence Questionnaire) | The Benzodiazepine Dependence Questionnaire (BDEPQ) is a 30 item self report questionnaire designed to measure dependence on benzodiazepine tranquilisers, sedatives and hypnotics. Items cover all aspects of the dependence syndrome with the exception of withdrawal symptoms. Each item is rated on a four point likert scale referring to experiences in the last month. BDEPQ score ranges from 0 (no dependence) to 85 (most severe dependence). | For patient with less than 75% items answered the BDEPQ-Score was not calculated. For only 132 patients Score was calculated. | Posted | Number | participants | Change from visit 2 (approx. 4 weeks after baseline) to last visit (end of observation- approx. 12 weeks after baseline) |
|
|
|
| Secondary | Change of RS-13 (Resilience Questionnaire) (Pre - Post) | RS-13 is a 13 items self Report questionnaire measure the resilience, which applies a reliance scale ranging from 13 (lowest stress resistance) to 91 (highest stress resistance). | Posted | Number | participants | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) |
|
|
|
| Secondary | Change in EQ-5D (Health Questionnaire) Scores (Pre - Post) | EQ-5Dâ„¢ is a standardised instrument for use as a measure of health Outcome The EQ-5D assesses five aspects of QoL: mobility, self-care, usual activity, pain/discomfort and anxiety/depression. An EQ-5D profile score of 0 points represents the worst QoL (death), while 1 point stands for full health. Data analysis was performed according to the EuroQol manual. The EQ-VAS ranges from 0 (worst QoL) to 100 (best QoL). | Posted | Number | participants | Change from Baseline (before treatment) to last visit (end of observation- approx. 12 weeks after baseline) |
|
|
|
| Secondary | Change of EQ-5D VAS Scores (Pre - Post) | VAS values (Quality of Life) range from 0 (very poor) to 100 (best possible state). | Posted | Number | participants | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) |
|
|
|
| Secondary | Tolerability Assess Using a 5 Point Scale | Assessment of tolerability using a 5 point scale (very good, good, satisfactory, bad, very bad) | Posted | Number | participants | Evaluation of Tolerability on visit 3 (appr. 12 weeks after baseline) |
|
|
|
| 0 |
| 154 |
| 3 |
| 154 |
| Numbness in limbs | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| Title | Measurements |
|---|---|
|
| bad |
|
| very bad |
|