Trial Outcomes & Findings for Tapentadol Versus Oxycodone - a Mechanism-based Treatment Approach in Neuropathic Pain (NCT NCT01458015)
NCT ID: NCT01458015
Last Updated: 2025-01-07
Results Overview
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.
TERMINATED
PHASE4
3 participants
day 0 (baseline) and day 78 (V6; 10 weeks)
2025-01-07
Participant Flow
Participant milestones
| Measure |
Tapentadol
received 200-500 mg Tapentadol PR (prolonged release), individual titration
|
Oxycodon Retard
received 40-120 mg Oxycodon CR (controled release), individual titration
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tapentadol Versus Oxycodone - a Mechanism-based Treatment Approach in Neuropathic Pain
Baseline characteristics by cohort
| Measure |
Oxycodone
n=1 Participants
tapentadol, oxycodone: tapentadol pr 100-500 mg oxycodone cr 20-120mg
|
Tapentadol
n=2 Participants
tapentadol, oxycodone: tapentadol pr 100-500 mg oxycodone cr 20-120mg
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
57 years
n=5 Participants
|
52 years
n=7 Participants
|
53.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
caucasian/european
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: day 0 (baseline) and day 78 (V6; 10 weeks)Population: Due to low number of participants only descriptive data is available
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.
Outcome measures
| Measure |
Oxycodone
n=2 Participants
received 40-120 mg Oxycodone CR, individual titration
|
Oxycodone
n=1 Participants
tapentadol, oxycodone: tapentadol pr 100-500 mg oxycodone cr 20-120mg
|
|---|---|---|
|
Mechanical Pain Threshold (MPT)
V1
|
2.6 Z-score
Interval 2.2 to 3.0
|
1.1 Z-score
Interval 1.1 to 1.1
|
|
Mechanical Pain Threshold (MPT)
V6
|
0.55 Z-score
Interval -1.9 to 3.0
|
—
|
PRIMARY outcome
Timeframe: day 0 (baseline) and day 78 (10 weeks)Population: Due to low number of participants only descriptive data is available
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.
Outcome measures
| Measure |
Oxycodone
n=1 Participants
received 40-120 mg Oxycodone CR, individual titration
|
Oxycodone
n=2 Participants
tapentadol, oxycodone: tapentadol pr 100-500 mg oxycodone cr 20-120mg
|
|---|---|---|
|
Heat Pain Threshold (HPT)
V1
|
-0.2 Z-score
Interval -0.2 to -0.2
|
-0.5 Z-score
Interval -1.8 to 2.8
|
|
Heat Pain Threshold (HPT)
V6
|
—
|
-1.4 Z-score
Interval -1.9 to -0.9
|
PRIMARY outcome
Timeframe: day 0 (baseline) and day 78 (10 weeks)Population: Due to low number of participants only descriptive data is available
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.
Outcome measures
| Measure |
Oxycodone
n=1 Participants
received 40-120 mg Oxycodone CR, individual titration
|
Oxycodone
n=2 Participants
tapentadol, oxycodone: tapentadol pr 100-500 mg oxycodone cr 20-120mg
|
|---|---|---|
|
Wind-Up Ratio (WUR)
V1
|
-0.2 Z-score
Interval -0.2 to -0.2
|
-0.6 Z-score
Interval -0.8 to -0.4
|
|
Wind-Up Ratio (WUR)
V6
|
—
|
0.75 Z-score
Interval -0.6 to 2.1
|
PRIMARY outcome
Timeframe: day 0 (baseline) and day 78 (10 weeks)Population: Due to low recruitement numbers only descriptive data is available
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.
Outcome measures
| Measure |
Oxycodone
n=1 Participants
received 40-120 mg Oxycodone CR, individual titration
|
Oxycodone
n=2 Participants
tapentadol, oxycodone: tapentadol pr 100-500 mg oxycodone cr 20-120mg
|
|---|---|---|
|
Cold Pain Threshold (CPT)
V1
|
-1.1 Z-score
Interval -1.1 to -1.1
|
0.35 Z-score
Interval -1.2 to 1.9
|
|
Cold Pain Threshold (CPT)
V6
|
—
|
0.35 Z-score
Interval -1.2 to 1.9
|
PRIMARY outcome
Timeframe: day 0 (baseline) and day 78 (V6; 10 weeks)Population: Due to low number of participants only descriptive data is available
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.
Outcome measures
| Measure |
Oxycodone
n=2 Participants
received 40-120 mg Oxycodone CR, individual titration
|
Oxycodone
n=1 Participants
tapentadol, oxycodone: tapentadol pr 100-500 mg oxycodone cr 20-120mg
|
|---|---|---|
|
Pressure Pain Threshold (PPT)
V1
|
1.65 Z-score
Interval -1.9 to 5.2
|
0 Z-score
Interval 0.0 to 0.0
|
|
Pressure Pain Threshold (PPT)
V6
|
0.9 Z-score
Interval -3.1 to 4.9
|
—
|
PRIMARY outcome
Timeframe: day 0 (baseline) and day 78 (V6; 10 weeks)Population: Due to low number of participants only descriptive data is available
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.
Outcome measures
| Measure |
Oxycodone
n=2 Participants
received 40-120 mg Oxycodone CR, individual titration
|
Oxycodone
n=1 Participants
tapentadol, oxycodone: tapentadol pr 100-500 mg oxycodone cr 20-120mg
|
|---|---|---|
|
Mechanical Pain Sensitivity (MPS)
V1
|
2 Z-score
Interval 1.8 to 2.2
|
2.2 Z-score
Interval 2.2 to 2.2
|
|
Mechanical Pain Sensitivity (MPS)
V6
|
1.5 Z-score
Interval -0.9 to 3.9
|
-0.4 Z-score
Interval -0.4 to -0.4
|
PRIMARY outcome
Timeframe: day 0 (baseline) and day 78 (V6; 10 weeks)Population: Due to low number of participants only descriptive data is available
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.
Outcome measures
| Measure |
Oxycodone
n=2 Participants
received 40-120 mg Oxycodone CR, individual titration
|
Oxycodone
n=1 Participants
tapentadol, oxycodone: tapentadol pr 100-500 mg oxycodone cr 20-120mg
|
|---|---|---|
|
Dynamic Mechanical Allodynia (DMA)
V1
|
44 score on a scale
Interval 40.0 to 48.0
|
41 score on a scale
Interval 41.0 to 41.0
|
|
Dynamic Mechanical Allodynia (DMA)
V6
|
5 score on a scale
Interval 1.0 to 9.0
|
2 score on a scale
Interval 2.0 to 2.0
|
PRIMARY outcome
Timeframe: day 0 (baseline) and day 78 (V6; 10 weeks)Change of pain upon Numeric Rating Scale (NRS; 0 = no pain at all; 10 = maximum pain imaginable) from V1 to V6
Outcome measures
| Measure |
Oxycodone
n=2 Participants
received 40-120 mg Oxycodone CR, individual titration
|
Oxycodone
n=1 Participants
tapentadol, oxycodone: tapentadol pr 100-500 mg oxycodone cr 20-120mg
|
|---|---|---|
|
Pain Upon Numeric Rating Scale
V1
|
9.5 score on a scale
Interval 9.0 to 10.0
|
6 score on a scale
Interval 6.0 to 6.0
|
|
Pain Upon Numeric Rating Scale
V6
|
5.5 score on a scale
Interval 4.0 to 7.0
|
3 score on a scale
Interval 3.0 to 3.0
|
SECONDARY outcome
Timeframe: day 0 (baseline) and day 78 (10 weeks)Population: Due to low number of participants only descriptive data can be provided.
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.
Outcome measures
| Measure |
Oxycodone
n=1 Participants
received 40-120 mg Oxycodone CR, individual titration
|
Oxycodone
n=2 Participants
tapentadol, oxycodone: tapentadol pr 100-500 mg oxycodone cr 20-120mg
|
|---|---|---|
|
Cold Detection Threshold (CDT)
V1
|
-2.3 Z-score
Interval -2.3 to -2.3
|
-1.2 Z-score
Interval -2.0 to -0.4
|
|
Cold Detection Threshold (CDT)
V6
|
—
|
-1.45 Z-score
Interval -1.9 to -1.0
|
SECONDARY outcome
Timeframe: day 0 (baseline) and day 78 (V6; 10 weeks)Population: Due to low number of participants only descriptive data is available
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.
Outcome measures
| Measure |
Oxycodone
n=2 Participants
received 40-120 mg Oxycodone CR, individual titration
|
Oxycodone
n=1 Participants
tapentadol, oxycodone: tapentadol pr 100-500 mg oxycodone cr 20-120mg
|
|---|---|---|
|
Warmth Detection Threshold (WDT)
V1
|
-1.05 Z-score
Interval -2.0 to -0.1
|
-2 Z-score
Interval -2.0 to -2.0
|
|
Warmth Detection Threshold (WDT)
V6
|
-2 Z-score
Interval -2.2 to -1.8
|
—
|
SECONDARY outcome
Timeframe: day 0 (baseline) and day 78 (V6; 10 weeks)Population: Due to low number of participants only descriptive data is available
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.
Outcome measures
| Measure |
Oxycodone
n=2 Participants
received 40-120 mg Oxycodone CR, individual titration
|
Oxycodone
n=1 Participants
tapentadol, oxycodone: tapentadol pr 100-500 mg oxycodone cr 20-120mg
|
|---|---|---|
|
Thermal Sensory Limen (TSL)
V1
|
-1.9 Z-score
Interval -3.9 to 0.1
|
-2.1 Z-score
Interval -2.1 to -2.1
|
|
Thermal Sensory Limen (TSL)
V6
|
-2.45 Z-score
Interval -2.6 to -2.3
|
—
|
SECONDARY outcome
Timeframe: day 0 (baseline) and day 78 (V6; 10 weeks)Population: Due to low number of participants only descriptive data is available
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.
Outcome measures
| Measure |
Oxycodone
n=2 Participants
received 40-120 mg Oxycodone CR, individual titration
|
Oxycodone
n=1 Participants
tapentadol, oxycodone: tapentadol pr 100-500 mg oxycodone cr 20-120mg
|
|---|---|---|
|
Mechanical Detection Threshold (MDT)
V1
|
-0.1 Z-score
Interval -0.2 to 0.0
|
-2.2 Z-score
Interval -2.2 to -2.2
|
|
Mechanical Detection Threshold (MDT)
V6
|
-1 Z-score
Interval -2.1 to 1.0
|
—
|
SECONDARY outcome
Timeframe: day 0 (baseline) and day 78 (V6; 10 weeks)Population: Due to low number of participants only descriptive data is available
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.
Outcome measures
| Measure |
Oxycodone
n=2 Participants
received 40-120 mg Oxycodone CR, individual titration
|
Oxycodone
n=1 Participants
tapentadol, oxycodone: tapentadol pr 100-500 mg oxycodone cr 20-120mg
|
|---|---|---|
|
Vibration Detection Threshold (VDT)
V1
|
-1.85 Z-score
Interval -4.8 to -1.1
|
-1.8 Z-score
Interval -1.8 to -1.8
|
|
Vibration Detection Threshold (VDT)
V6
|
-1.72 Z-score
Interval -3.3 to 0.0
|
—
|
SECONDARY outcome
Timeframe: day 0 (baseline) and day 78 (V6; 10 weeks)Population: Due to low number of participants only descriptive data is available
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.
Outcome measures
| Measure |
Oxycodone
n=2 Participants
received 40-120 mg Oxycodone CR, individual titration
|
Oxycodone
n=1 Participants
tapentadol, oxycodone: tapentadol pr 100-500 mg oxycodone cr 20-120mg
|
|---|---|---|
|
Paradoxical Heat Sensations (PHS)
V1
|
0.5 sensations out of 3
Interval 0.0 to 1.0
|
0 sensations out of 3
Interval 0.0 to 0.0
|
|
Paradoxical Heat Sensations (PHS)
V6
|
0 sensations out of 3
Interval 0.0 to 0.0
|
—
|
Adverse Events
Tapentadol Retard
Oxycodon Retard
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tapentadol Retard
n=2 participants at risk
daily dose of max. 500 mg and min. 200 mg
|
Oxycodon Retard
n=1 participants at risk
daily dose of max. 120 mg and min. 40 mg
|
|---|---|---|
|
Gastrointestinal disorders
diarrhea
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
|
Gastrointestinal disorders
vomiting/nausea
|
50.0%
1/2 • Number of events 1
|
100.0%
1/1 • Number of events 2
|
|
General disorders
fatigue
|
50.0%
1/2
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
pruritus
|
50.0%
1/2
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
swollen, red, hot left knee
|
50.0%
1/2
|
0.00%
0/1
|
|
Nervous system disorders
dizzieness
|
0.00%
0/2
|
100.0%
1/1
|
|
Skin and subcutaneous tissue disorders
hyperhidrosis
|
50.0%
1/2
|
0.00%
0/1
|
|
Nervous system disorders
difficulty concentrating
|
0.00%
0/2
|
100.0%
1/1
|
|
Skin and subcutaneous tissue disorders
eczema of the left hand
|
50.0%
1/2
|
0.00%
0/1
|
|
Nervous system disorders
headache
|
50.0%
1/2
|
100.0%
1/1
|
Additional Information
Prof. Ralf Baron
Universitätsklinikum Schleswig-Holstein, Campus Kiel; Sektion neurologische Schmerzforschung und -therapie
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place