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Clinical Trials/EUCTR2011-003628-11-DE
EUCTR2011-003628-11-DEActive, not recruitingNot Applicable

Tapentadol PR vs Oxycodon CRA pilotstudiy for a mechanism-orientated Therapy of peripheral chronic neuropathic pain syndrom - Tapentadol PR vs Oxycodon CR

niversity Hospital Schleswig Holstein Kiel, Clinic of Neurology0 sitesStarted: September 27, 2011Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Possible or manifested peripheral neuropathic pain syndrome (one of four: post-zosteric neuralgia, polyneuropathia, peripheral nerver injury, radikulopathy)
  • •2. Analgesics (WHO III) required according to assessment of treating MD.
  • •3. At least one parameter in QST-measurement within painful body area for MPT, MPS, DM and/or WUR with a Z-value >1.5 and/or a pathological side difference for one of these parameters.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 38
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

  • •1. Diagnosis of an active systemic or local infection which would represent an influence on the assessment of efficacy, quality of life/function or safety according to the determination by the treating investigator.
  • •2. Earlier alcohol-, drug-, medication abuse or suspicion by investigator
  • •3. Diagnosis of a concomittant, inflammatory auto immune disease.
  • •4. Severe kidney insufficiency (GFR < 30 mL/min.)
  • •5. Currently existing or according to labortory values confirmed mediocre to severe liver disfunction (GOT or GPT > 2x normal value)
  • •6. Epilepsy

Investigators

Sponsor
niversity Hospital Schleswig Holstein Kiel, Clinic of Neurology

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