Clinical trial NCT01416116: Method of Pre-treatment for Application of QUTENZA Capsaicin 8% Patch
Official title: Tolerability of QUTENZATM When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: or Peripheral Nerve Injury (PNI)
Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN)
Keywords: Tramadol
QUTENZA
Pre-treatment
Tolerability
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2011-08-12
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: All patients will be treated with QUTENZA for 60 minutes. Patients will be randomized to one of two arms- application of topical anaesthetic (lidocaine cream) or an oral analgesic (tramadol oral tables) prior to application of QUTENZA. Patients will be followed up for 7 days to monitor pain scores and tolerability.

Eligibility criteria: 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

Primary outcomes:
measure: The proportion of subjects who tolerate QUTENZA treatment
timeFrame: 60 minute application period
Secondary outcomes:
measure: Duration of patch application
timeFrame: 60 minutes
measure: Change in pain scores from baseline to subsequent timepoints on the day of patch application
timeFrame: 5, 25, 55, 85, 115 minutes on day of application and once a day on days 1, 2, 3
measure: Proportion of subjects using pain medications and dose of pain medication(s) administered
timeFrame: day 1-5
measure: Subject rated tolerability score
timeFrame: Baseline to end of study visit, day 7
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Site 102
city: Genk
country: Belgium
facility: Site 103
city: Roeselare
country: Belgium
facility: Site 101
city: Hradec Králové
country: Czechia
facility: Site 202
city: Olomouc
country: Czechia
facility: Site 203
city: Prague
country: Czechia
facility: Site 201
city: Aalborg
country: Denmark
facility: Site 302
city: Aarhus
country: Denmark
facility: Site 301
city: Cork
country: Ireland
facility: Site 402
city: Galway
country: Ireland
facility: Site 403
city: Galway
country: Ireland
facility: Site 404
city: Limerick
country: Ireland
facility: Site 401
city: Hamar
country: Norway
facility: Site 502
city: Skien
country: Norway
facility: Site 501
city: Kosice
country: Slovakia
facility: Site 603
city: Martin
country: Slovakia
facility: Site 602
city: Glasgow
country: United Kingdom
facility: Site 702
city: Liverpool
country: United Kingdom
facility: Site 701
city: Manchester
country: United Kingdom
facility: Site 704
city: Solihull
country: United Kingdom
facility: Site 703
Study officials:
affiliation: Astellas Pharma Europe Limited
name: Senior Study Manager, Late Phase Clinical Development & Operations
role: STUDY_DIRECTOR
References: