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

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

Overview[ - collapse ][ - ]

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	Peripheral Neuropathy
Intervention	Drug: tapentadol, oxycodone
Phase	Phase 4
Sponsor	University of Schleswig-Holstein
Responsible Party	University of Schleswig-Holstein
ClinicalTrials.gov Identifier	NCT01458015
First Received	August 5, 2011
Last Updated	March 25, 2014
Last verified	March 2014

Tracking Information[ + expand ][ + ]

First Received Date	August 5, 2011
Last Updated Date	March 25, 2014
Start Date	October 2011
Estimated Primary Completion Date	November 2013
Current 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]
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	Tapentadol Versus Oxycodon - a Mechanism-based Treatment Approach in Neuropathic Pain
Official Title	Phase 4 Study of Tapentadol vs Oxycodone in Neuropathic Pain
Brief Summary	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	Not Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Condition	Peripheral Neuropathy
Intervention	Drug: tapentadol, oxycodone tapentadol pr 100-500 mg oxycodone cr 20-120mg Other Names: Palexia
Study Arm (s)	Active Comparator: oxycodone Active Comparator: tapentadol

Recruitment Information[ + expand ][ + ]

Recruitment Status	Terminated
Estimated Enrollment	5
Estimated Completion Date	November 2013
Estimated Primary Completion Date	November 2013
Eligibility Criteria	Inclusion Criteria: - thermal or mechanical hyperalgesia - chronic neuropathic pain (NRS => 6) Exclusion Criteria: - non-specific
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Germany

Administrative Information[ + expand ][ + ]

NCT Number	NCT01458015
Other Study ID Numbers	TapOxy01
Has Data Monitoring Committee	No
Information Provided By	University of Schleswig-Holstein
Study Sponsor	University of Schleswig-Holstein
Collaborators	Not Provided
Investigators	Principal Investigator: Ralf Baron, Prof. Dr. Head of Unit of Neuropathic Pain Research and Therapy, Department of Neurology, University Clinic Kiel
Verification Date	March 2014

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