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

This study is currently recruiting participants.
Verified June 2012 by University of Schleswig-Holstein
Sponsor:
Information provided by (Responsible Party):
Ralf Baron, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT01458015
First received: August 5, 2011
Last updated: June 6, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Peripheral Neuropathy
 Drug: tapentadol, oxycodone
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Phase 4 Study of Tapentadol vs Oxycodone in Neuropathic Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:
  • QST parameters on mechanical and thermal thresholds (detailed below) [ Time Frame: day 0 (baseline) and day 78 (10 weeks) ] [ Designated as safety issue: No ]
    change from baseline in mechanical and thermal pain thresholds and sensitivity measured by QST

  • mechanical pain threshold (MPT) [ Time Frame: day 0 (baseline) and day 78 (10 weeks) ] [ Designated as safety issue: No ]
  • mechanical pain sensitivity (MPS) [ Time Frame: day 0 (baseline) and day 78 (10 weeks) ] [ Designated as safety issue: No ]
  • dynamic mechanicl allodynia (DMA) [ Time Frame: day 0 (baseline) and day 78 (10 weeks) ] [ Designated as safety issue: No ]
  • wind-up ratio (WUR) [ Time Frame: day 0 (baseline) and day 78 (10 weeks) ] [ Designated as safety issue: No ]

Estimated Enrollment: 52
Study Start Date: October 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: oxycodone Drug: tapentadol, oxycodone
tapentadol pr 100-500 mg oxycodone cr 20-120mg
Other Name: Palexia
Active Comparator: tapentadol Drug: tapentadol, oxycodone
tapentadol pr 100-500 mg oxycodone cr 20-120mg
Other Name: Palexia

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • non-specific
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01458015

Contacts
Contact: Ralf Baron, Prof Dr 00494315978505 r.baron@neurologie.uni-kiel.de

Locations
Germany
Division for Neurological Pain Research and Therapy Recruiting
Kiel, Schleswig Holstein, Germany, 24105
Sub-Investigator: Andreas Binder, Dr            
Sponsors and Collaborators
University of Schleswig-Holstein
Investigators
Principal Investigator: Ralf Baron, Prof. Dr. Head of Unit of Neuropathic Pain Research and Therapy, Department of Neurology, University Clinic Kiel
  More Information

No publications provided

Responsible Party: Ralf Baron, Prof. Dr. med., University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT01458015     History of Changes
Other Study ID Numbers: TapOxy01
Study First Received: August 5, 2011
Last Updated: June 6, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Schleswig-Holstein:
QST
neuropathic pain
tapentadol pr
oxycodone

Additional relevant MeSH terms:
Neuralgia
Peripheral Nervous System Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Oxycodone
Narcotics
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 19, 2013