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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-003628-11-DE
Enrollment
Unknown
Registered
2011-09-27
Start date
2011-10-26
Completion date
Unknown
Last updated
2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronical neuropathic pain syndrome

Interventions

Trade Name: Palexia (R) retard Product Name: Palexia Pharmaceutical Form: Tablet Trade Name: Oxygesic® Product Name: Oxygesic Pharmaceutical Form: Tablet

Sponsors

University Hospital Schleswig Holstein Kiel, Clinic of Neurology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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 2x normal value) 6. Epilepsy

Design outcomes

Primary

MeasureTime frame
Main Objective: It shall be answered if Tapentadol PR compared to Oxycodon CR leads to a normalization of abnormal QST-Parameters (MPT, MPS, DMA and/or WUR with a Z-Value > 1,5 and/or a pathological side difference for these Parameters);Secondary Objective: ;Primary end point(s): Spontaneous intensity of pain (NRS-3);Timepoint(s) of evaluation of this end point: End of treatment—

Countries

Germany

Contacts

Public ContactProf. Dr. Rald Baron

University Hospital Schleswig Holstein Kiel, Clinic of Neurology

r.baron@neurologie.uni-kiel.de00494315978504

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026