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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01458015
Recruitment Status : Terminated
First Posted : October 24, 2011
Last Update Posted : March 26, 2014
Information provided by (Responsible Party):
Ralf Baron, University of Schleswig-Holstein

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.

Condition or disease Intervention/treatment Phase
Peripheral Neuropathy Drug: tapentadol, oxycodone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Phase 4 Study of Tapentadol vs Oxycodone in Neuropathic Pain
Study Start Date : October 2011
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. QST parameters on mechanical and thermal thresholds (detailed below) [ Time Frame: day 0 (baseline) and day 78 (10 weeks) ]
    change from baseline in mechanical and thermal pain thresholds and sensitivity measured by QST

  2. mechanical pain threshold (MPT) [ Time Frame: day 0 (baseline) and day 78 (10 weeks) ]
  3. mechanical pain sensitivity (MPS) [ Time Frame: day 0 (baseline) and day 78 (10 weeks) ]
  4. dynamic mechanicl allodynia (DMA) [ Time Frame: day 0 (baseline) and day 78 (10 weeks) ]
  5. wind-up ratio (WUR) [ Time Frame: day 0 (baseline) and day 78 (10 weeks) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • non-specific

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01458015

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

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Responsible Party: Ralf Baron, Prof. Dr. med., University of Schleswig-Holstein Identifier: NCT01458015     History of Changes
Other Study ID Numbers: TapOxy01
First Posted: October 24, 2011    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: March 2014

Keywords provided by Ralf Baron, University of Schleswig-Holstein:
neuropathic pain
tapentadol pr

Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents