CompletedPhase 4

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

Belgium, Czechia122 participantsStarted 2011-07-06

Plain-language 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.

Who can participate

Age range18 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of postherpetic neuralgia or neuropathic pain due to peripheral nerve injury * Daily pain score ≥ 4 for average pain both at the Screening Visit and at the Treatment Visit * Intact, non-irritated, dry skin over the painful area(s) to be treated Exclusion Criteria: * Significant ongoing or recurrent pain other than due to PHN or peripheral nerve injury * Past or current history of Type I or Type II diabetes mellitus * Active malignancy or treatment for malignancy within a year prior to the Treatment Visit

What they're measuring

The proportion of subjects who tolerate QUTENZA treatment

Timeframe: 60 minute application period

Trial details

NCT IDNCT01416116

SponsorAstellas Pharma Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-04-25

View on ClinicalTrials.gov More or Peripheral Nerve Injury (PNI) trials