or Peripheral Nerve Injury (PNI) Clinical Trial
— LIFTOfficial 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
| Verified date | April 2018 |
| Source | Astellas Pharma Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 122 |
| Est. completion date | April 25, 2012 |
| Est. primary completion date | April 25, 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 90 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Site 102 | Antwerpen | |
| Belgium | Site 103 | Genk | |
| Belgium | Site 101 | Roeselare | |
| Czechia | Site 202 | Hradec Králové | |
| Czechia | Site 203 | Olomouc | |
| Czechia | Site 201 | Prague | |
| Denmark | Site 302 | Aalborg | |
| Denmark | Site 301 | Aarhus | |
| Ireland | Site 402 | Cork | |
| Ireland | Site 403 | Galway | |
| Ireland | Site 404 | Galway | |
| Ireland | Site 401 | Limerick | |
| Norway | Site 502 | Hamar | |
| Norway | Site 501 | Skien | |
| Slovakia | Site 603 | Kosice | |
| Slovakia | Site 602 | Martin | |
| United Kingdom | Site 702 | Glasgow | |
| United Kingdom | Site 701 | Liverpool | |
| United Kingdom | Site 704 | Manchester | |
| United Kingdom | Site 703 | Solihull |
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Pharma Inc |
Belgium, Czechia, Denmark, Ireland, Norway, Slovakia, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The proportion of subjects who tolerate QUTENZA treatment | A QUTENZA tolerant subject is defined as a subject receiving at least 90% of the intended patch duration. | 60 minute application period | |
| Secondary | Duration of patch application | 60 minutes | ||
| Secondary | 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 | ||
| Secondary | Proportion of subjects using pain medications and dose of pain medication(s) administered | day 1-5 | ||
| Secondary | Subject rated tolerability score | Baseline to end of study visit, day 7 |