Tapentadol Versus Oxycodone - a Mechanism-based Treatment Approach in Neuropathic Pain

Phase 4 Study of Tapentadol vs Oxycodone in Neuropathic Pain

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.

Study Overview

• Status: Terminated
• Conditions: Peripheral Neuropathy
• Intervention / Treatment: Drug: tapentadol, oxycodone

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Schleswig Holstein
    • Kiel, Schleswig Holstein, Germany, 24105
      • Division for Neurological Pain Research and Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• thermal or mechanical hyperalgesia
• chronic neuropathic pain (NRS => 6)

Exclusion Criteria:

• non-specific

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: oxycodone	Drug: tapentadol, oxycodone; tapentadol pr 100-500 mg oxycodone cr 20-120mg; Other Names: Palexia
Active Comparator: tapentadol	Drug: tapentadol, oxycodone; tapentadol pr 100-500 mg oxycodone cr 20-120mg; Other Names: Palexia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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)

Secondary Outcome Measures

Outcome Measure	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.	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)

Collaborators and Investigators

• Sponsor: University Hospital Schleswig-Holstein
• Investigators: Principal Investigator: Ralf Baron, Prof. Dr., Head of Unit of Neuropathic Pain Research and Therapy, Department of Neurology, University Clinic Kiel

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: August 5, 2011
• First Submitted That Met QC Criteria: October 20, 2011
• First Posted (Estimated): October 24, 2011

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: neuropathic pain; oxycodone; tapentadol pr; QST (quantitative sensory testing)
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Neuralgia; Peripheral Nervous System Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Neurotransmitter Agents; Membrane Transport Modulators; Adrenergic Agents; Neurotransmitter Uptake Inhibitors; Adrenergic Uptake Inhibitors; Tapentadol; Oxycodone
• Other Study ID Numbers: TapOxy01