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Method of Pre-treatment for Application of QUTENZA Capsaicin 8% Patch

NCT01416116 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2018-04-23

No results posted yet for this study

Summary

The Summary of product characteristics (SmPC) for QUTENZA advises that topical anaesthetic is applied prior to the application of QUTENZA. This is a multi-center, randomized, assessor-blinded study which will investigate the use of an oral analgesic as an alternative form of pre-treatment for QUTENZA.

Conditions

  • or Peripheral Nerve Injury (PNI)
  • Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN)

Interventions

DRUG

QUTENZA

topical

DRUG

Lidocaine

topical

DRUG

Tramadol

oral

Sponsors & Collaborators

  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Senior Study Manager, Late Phase Clinical Development & Operations · Astellas Pharma Europe Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-06
Primary Completion
2012-04-25
Completion
2012-04-25

Countries

  • Belgium
  • Czechia
  • Denmark
  • Ireland
  • Norway
  • Slovakia
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01416116 on ClinicalTrials.gov