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The purpose of this study is to elucidate whether the additional mechanism of analgesia, i.e. reuptake inhibition of norepinephrine, of tapentadol leads to a change in different pain signs and symptoms in comparison to oxycodone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oxycodone | Active Comparator |
| |
| tapentadol | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tapentadol, oxycodone | Drug | tapentadol pr 100-500 mg oxycodone cr 20-120mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mechanical Pain Threshold (MPT) | Change of Mechanical Pain Threshold from baseline to V6 The mechanical pain threshold (MPT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement. | day 0 (baseline) and day 78 (V6; 10 weeks) |
| Heat Pain Threshold (HPT) | Change of Heat Pain Threshold from V1 to V6 The was Heat Pain Threshold (HPT)measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement. | day 0 (baseline) and day 78 (10 weeks) |
| Wind-Up Ratio (WUR) | Change of Wind-Up Ratio from V1 to V6 The Wind-Up Ratio (WUR) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement. |
| Measure | Description | Time Frame |
|---|---|---|
| Cold Detection Threshold (CDT) | Change of Cold Detection Threshold from V1 to V6 The Cold Detection Threshold (CDT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.). A higher z-value indicates an improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ralf Baron, Prof. Dr. | Head of Unit of Neuropathic Pain Research and Therapy, Department of Neurology, University Clinic Kiel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division for Neurological Pain Research and Therapy | Kiel | Schleswig-Holstein | 24105 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tapentadol | received 200-500 mg Tapentadol PR (prolonged release), individual titration |
| FG001 | Oxycodon Retard | received 40-120 mg Oxycodon CR (controled release), individual titration |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxycodone | tapentadol, oxycodone: tapentadol pr 100-500 mg oxycodone cr 20-120mg |
| BG001 | Tapentadol | tapentadol, oxycodone: tapentadol pr 100-500 mg oxycodone cr 20-120mg |
| 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 | Mechanical Pain Threshold (MPT) | Change of Mechanical Pain Threshold from baseline to V6 The mechanical pain threshold (MPT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement. | Due to low number of participants only descriptive data is available | Posted | Mean | Full Range | Z-score | day 0 (baseline) and day 78 (V6; 10 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 | Tapentadol Retard | daily dose of max. 500 mg and min. 200 mg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhea | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Ralf Baron | Universitätsklinikum Schleswig-Holstein, Campus Kiel; Sektion neurologische Schmerzforschung und -therapie | +4943123911 | r.baron@neurologie.uni-kiel.de |
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000077432 | Tapentadol |
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| day 0 (baseline) and day 78 (10 weeks) |
| Cold Pain Threshold (CPT) | Change of Cold Pain Threshold from baseline to V6 The Cold Pain Threshold (CPT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement. | day 0 (baseline) and day 78 (10 weeks) |
| Pressure Pain Threshold (PPT) | Change of Pressure Pain Threshold from V1 to V6 The Pressure Pain Threshold (PPT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement. | day 0 (baseline) and day 78 (V6; 10 weeks) |
| Mechanical Pain Sensitivity (MPS) | Change of Mechanical Pain Sensitivity from V1 to V6 The Mechanical Pain Sensitivity (MPS) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement. | day 0 (baseline) and day 78 (V6; 10 weeks) |
| Dynamic Mechanical Allodynia (DMA) | Change of Dynamic Mechanical Allodynia from V1 to V6 The Dynamic Mechanical Allodynia (DMA) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). "Subjects were asked to give a pain rating for each stimulus on a '0-100' numerical rating scale ('0' indicating "no pain", and '100' indicating "most intense pain imaginable")." See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. A lower score indicates an improvement. | day 0 (baseline) and day 78 (V6; 10 weeks) |
| Pain Upon Numeric Rating Scale | Change of pain upon Numeric Rating Scale (NRS; 0 = no pain at all; 10 = maximum pain imaginable) from V1 to V6 | day 0 (baseline) and day 78 (V6; 10 weeks) |
| day 0 (baseline) and day 78 (10 weeks) |
| Warmth Detection Threshold (WDT) | Change of Warmth Detection Threshold from V1 to V6 The Warmth Detection Threshold (WDT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.). A higher z-value indicates an improvement. | day 0 (baseline) and day 78 (V6; 10 weeks) |
| Thermal Sensory Limen (TSL) | Change of Thermal Sensory Limen from V1 to V6 The Thermal Sensory Limen (TSL) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Logarithmically trasnformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.). A higher z-value indicates an improvement. | day 0 (baseline) and day 78 (V6; 10 weeks) |
| Mechanical Detection Threshold (MDT) | Change of Mechanical Detection Threshold from V1 to V6 The Mechanical Detection Threshold (MDT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.). A higher z-value indicates an improvement. | day 0 (baseline) and day 78 (V6; 10 weeks) |
| Vibration Detection Threshold (VDT) | Change of Vibration Detection Threshold from V1 to V6 The Vibration Detection Threshold (VDT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.). A higher z-value indicates an improvement. | day 0 (baseline) and day 78 (V6; 10 weeks) |
| Paradoxical Heat Sensations (PHS) | Change of Number of Paradoxical Heat Sensations from V1 to V6 The number of Paradoxical Heat Sensations (PHS) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. An occurence of up to three paradoxical heat sensations was possible. The number was assessed. A lower number indicates an improvement. | day 0 (baseline) and day 78 (V6; 10 weeks) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Oxycodone |
tapentadol, oxycodone: tapentadol pr 100-500 mg oxycodone cr 20-120mg |
| OG001 | Tapentadol | tapentadol, oxycodone: tapentadol pr 100-500 mg oxycodone cr 20-120mg |
|
|
| Primary | Heat Pain Threshold (HPT) | Change of Heat Pain Threshold from V1 to V6 The was Heat Pain Threshold (HPT)measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement. | Due to low number of participants only descriptive data is available | Posted | Mean | Full Range | Z-score | day 0 (baseline) and day 78 (10 weeks) |
|
|
|
| Primary | Wind-Up Ratio (WUR) | Change of Wind-Up Ratio from V1 to V6 The Wind-Up Ratio (WUR) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement. | Due to low number of participants only descriptive data is available | Posted | Mean | Full Range | Z-score | day 0 (baseline) and day 78 (10 weeks) |
|
|
|
| Primary | Cold Pain Threshold (CPT) | Change of Cold Pain Threshold from baseline to V6 The Cold Pain Threshold (CPT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement. | Due to low recruitement numbers only descriptive data is available | Posted | Mean | Full Range | Z-score | day 0 (baseline) and day 78 (10 weeks) |
|
|
|
| Primary | Pressure Pain Threshold (PPT) | Change of Pressure Pain Threshold from V1 to V6 The Pressure Pain Threshold (PPT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement. | Due to low number of participants only descriptive data is available | Posted | Mean | Full Range | Z-score | day 0 (baseline) and day 78 (V6; 10 weeks) |
|
|
|
| Primary | Mechanical Pain Sensitivity (MPS) | Change of Mechanical Pain Sensitivity from V1 to V6 The Mechanical Pain Sensitivity (MPS) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement. | Due to low number of participants only descriptive data is available | Posted | Mean | Full Range | Z-score | day 0 (baseline) and day 78 (V6; 10 weeks) |
|
|
|
| Primary | Dynamic Mechanical Allodynia (DMA) | Change of Dynamic Mechanical Allodynia from V1 to V6 The Dynamic Mechanical Allodynia (DMA) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). "Subjects were asked to give a pain rating for each stimulus on a '0-100' numerical rating scale ('0' indicating "no pain", and '100' indicating "most intense pain imaginable")." See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. A lower score indicates an improvement. | Due to low number of participants only descriptive data is available | Posted | Mean | Full Range | score on a scale | day 0 (baseline) and day 78 (V6; 10 weeks) |
|
|
|
| Primary | Pain Upon Numeric Rating Scale | Change of pain upon Numeric Rating Scale (NRS; 0 = no pain at all; 10 = maximum pain imaginable) from V1 to V6 | Posted | Mean | Full Range | score on a scale | day 0 (baseline) and day 78 (V6; 10 weeks) |
|
|
|
| Secondary | Cold Detection Threshold (CDT) | Change of Cold Detection Threshold from V1 to V6 The Cold Detection Threshold (CDT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.). A higher z-value indicates an improvement. | Due to low number of participants only descriptive data can be provided. | Posted | Mean | Full Range | Z-score | day 0 (baseline) and day 78 (10 weeks) |
|
|
|
| Secondary | Warmth Detection Threshold (WDT) | Change of Warmth Detection Threshold from V1 to V6 The Warmth Detection Threshold (WDT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.). A higher z-value indicates an improvement. | Due to low number of participants only descriptive data is available | Posted | Mean | Full Range | Z-score | day 0 (baseline) and day 78 (V6; 10 weeks) |
|
|
|
| Secondary | Thermal Sensory Limen (TSL) | Change of Thermal Sensory Limen from V1 to V6 The Thermal Sensory Limen (TSL) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Logarithmically trasnformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.). A higher z-value indicates an improvement. | Due to low number of participants only descriptive data is available | Posted | Mean | Full Range | Z-score | day 0 (baseline) and day 78 (V6; 10 weeks) |
|
|
|
| Secondary | Mechanical Detection Threshold (MDT) | Change of Mechanical Detection Threshold from V1 to V6 The Mechanical Detection Threshold (MDT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.). A higher z-value indicates an improvement. | Due to low number of participants only descriptive data is available | Posted | Mean | Full Range | Z-score | day 0 (baseline) and day 78 (V6; 10 weeks) |
|
|
|
| Secondary | Vibration Detection Threshold (VDT) | Change of Vibration Detection Threshold from V1 to V6 The Vibration Detection Threshold (VDT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.). A higher z-value indicates an improvement. | Due to low number of participants only descriptive data is available | Posted | Mean | Full Range | Z-score | day 0 (baseline) and day 78 (V6; 10 weeks) |
|
|
|
| Secondary | Paradoxical Heat Sensations (PHS) | Change of Number of Paradoxical Heat Sensations from V1 to V6 The number of Paradoxical Heat Sensations (PHS) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. An occurence of up to three paradoxical heat sensations was possible. The number was assessed. A lower number indicates an improvement. | Due to low number of participants only descriptive data is available | Posted | Mean | Full Range | sensations out of 3 | day 0 (baseline) and day 78 (V6; 10 weeks) |
|
|
|
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | Oxycodon Retard | daily dose of max. 120 mg and min. 40 mg | 0 | 1 | 1 | 1 |
| vomiting/nausea | Gastrointestinal disorders |
|
| fatigue | General disorders |
|
| pruritus | Skin and subcutaneous tissue disorders |
|
| swollen, red, hot left knee | Musculoskeletal and connective tissue disorders |
|
| dizzieness | Nervous system disorders |
|
| hyperhidrosis | Skin and subcutaneous tissue disorders |
|
| difficulty concentrating | Nervous system disorders |
|
| eczema of the left hand | Skin and subcutaneous tissue disorders |
|
| headache | Nervous system disorders |
|
Not provided
Not provided
Not provided
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| V6 |
|
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| V6 |
|
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| V6 |
|
|
| V6 |
|
|
| V6 |
|
|
| V6 |
|
|
| V6 |
|
|
| V6 |
|
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| V6 |
|
|
| V6 |
|
|