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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Ralf Baron, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT01458015
First received: August 5, 2011
Last updated: March 25, 2014
Last verified: March 2014
  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:


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 ]

Enrollment: 5
Study Start Date: October 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01458015

Locations
Germany
Division for Neurological Pain Research and Therapy
Kiel, Schleswig Holstein, Germany, 24105
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: March 25, 2014
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
Analgesics, Opioid
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

ClinicalTrials.gov processed this record on August 26, 2014