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

NCT01458015 | Terminated Phase 4 Results

• 1 other identifier: TapOxy01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peripheral Neuropathy

Keywords

QST (quantitative sensory testing); neuropathic pain; tapentadol pr; oxycodone

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (6)

• Cold Detection Threshold (CDT)

  day 0 (baseline) and day 78 (10 weeks)

• Warmth Detection Threshold (WDT)

  day 0 (baseline) and day 78 (V6; 10 weeks)

• Thermal Sensory Limen (TSL)

  day 0 (baseline) and day 78 (V6; 10 weeks)

• Mechanical Detection Threshold (MDT)

  day 0 (baseline) and day 78 (V6; 10 weeks)

• Vibration Detection Threshold (VDT)

  day 0 (baseline) and day 78 (V6; 10 weeks)

Study Arms (2)

oxycodone

ACTIVE COMPARATOR

Drug: tapentadol, oxycodone

tapentadol

ACTIVE COMPARATOR

Drug: tapentadol, oxycodone

Interventions

tapentadol, oxycodone DRUG

tapentadol pr 100-500 mg oxycodone cr 20-120mg

Also known as: Palexia

oxycodone; tapentadol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• non-specific

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

Division for Neurological Pain Research and Therapy

Kiel, Schleswig-Holstein, 24105, Germany

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Neuralgia

Interventions

Tapentadol; Oxycodone

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Prof. Ralf Baron
• Organization: Universitätsklinikum Schleswig-Holstein, Campus Kiel; Sektion neurologische Schmerzforschung und -therapie

r.baron@neurologie.uni-kiel.de

+4943123911

Study Officials

• Ralf Baron, Prof. Dr.

  Head of Unit of Neuropathic Pain Research and Therapy, Department of Neurology, University Clinic Kiel

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: August 5, 2011
• First Posted: October 24, 2011
• Study Start: October 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 7, 2025
• Results First Posted: December 17, 2024

Record last verified: 2024-12

Locations

DE (1)