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

NCT ID: NCT01458015

Last Updated: 2025-01-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Peripheral Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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oxycodone

Group Type ACTIVE_COMPARATOR

tapentadol, oxycodone

Intervention Type DRUG

tapentadol pr 100-500 mg oxycodone cr 20-120mg

tapentadol

Group Type ACTIVE_COMPARATOR

tapentadol, oxycodone

Intervention Type DRUG

tapentadol pr 100-500 mg oxycodone cr 20-120mg

Interventions

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tapentadol, oxycodone

tapentadol pr 100-500 mg oxycodone cr 20-120mg

Intervention Type DRUG

Other Intervention Names

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Palexia

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* non-specific
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Schleswig-Holstein

OTHER

Sponsor Role lead

Responsible Party

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Ralf Baron

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ralf Baron, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Head of Unit of Neuropathic Pain Research and Therapy, Department of Neurology, University Clinic Kiel

Locations

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Division for Neurological Pain Research and Therapy

Kiel, Schleswig-Holstein, Germany

Site Status

Countries

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Germany

Other Identifiers

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TapOxy01

Identifier Type: -

Identifier Source: org_study_id

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