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

• Conditions: Chronical neuropathic pain syndrome; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-003628-11-DE
• Lead Sponsor: niversity Hospital Schleswig Holstein Kiel, Clinic of Neurology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-27
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified