or Peripheral Nerve Injury (PNI), Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN)
Conditions
Keywords
Tramadol, QUTENZA, Pre-treatment, Tolerability
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.
Interventions
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of subjects who tolerate QUTENZA treatment | 60 minute application period | A QUTENZA tolerant subject is defined as a subject receiving at least 90% of the intended patch duration. |
Secondary
| Measure | Time frame |
|---|---|
| Duration of patch application | 60 minutes |
| Change in pain scores from baseline to subsequent timepoints on the day of patch application | 5, 25, 55, 85, 115 minutes on day of application and once a day on days 1, 2, 3 |
| Proportion of subjects using pain medications and dose of pain medication(s) administered | day 1-5 |
| Subject rated tolerability score | Baseline to end of study visit, day 7 |
Countries
Belgium, Czechia, Denmark, Ireland, Norway, Slovakia, United Kingdom
Outcome results
None listed