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

Peripheral Neuropathy Clinical Trial

Official title:

Phase 4 Study of Tapentadol vs Oxycodone in Neuropathic Pain

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01458015
• Other study ID #: TapOxy01
• Status: Terminated
• Phase: Phase 4
• First received: August 5, 2011
• Last updated: March 25, 2014
• Start date: October 2011
• Est. completion date: November 2013

Study information

• Verified date: March 2014
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• thermal or mechanical hyperalgesia

• chronic neuropathic pain (NRS => 6)

Exclusion Criteria:

• non-specific

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Neuralgia
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Drug:
• tapentadol, oxycodone
tapentadol pr 100-500 mg oxycodone cr 20-120mg

Locations

Country	Name	City	State
Germany	Division for Neurological Pain Research and Therapy	Kiel	Schleswig Holstein

Sponsors (1)

Lead Sponsor	Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QST parameters on mechanical and thermal thresholds (detailed below)	change from baseline in mechanical and thermal pain thresholds and sensitivity measured by QST	day 0 (baseline) and day 78 (10 weeks)	No
Primary	mechanical pain threshold (MPT)		day 0 (baseline) and day 78 (10 weeks)	No
Primary	mechanical pain sensitivity (MPS)		day 0 (baseline) and day 78 (10 weeks)	No
Primary	dynamic mechanicl allodynia (DMA)		day 0 (baseline) and day 78 (10 weeks)	No
Primary	wind-up ratio (WUR)		day 0 (baseline) and day 78 (10 weeks)	No