Trials / Completed
CompletedNCT01416116
Method of Pre-treatment for Application of QUTENZA Capsaicin 8% Patch
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 122 (actual)
- Sponsor
- Astellas Pharma Inc · Industry
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- or Peripheral Nerve Injury (PNI)
- Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | QUTENZA | topical |
| DRUG | Lidocaine | topical |
| DRUG | Tramadol | oral |
Timeline
- Start date
- 2011-07-06
- Primary completion
- 2012-04-25
- Completion
- 2012-04-25
- First posted
- 2011-08-12
- Last updated
- 2018-04-23
Locations
20 sites across 7 countries: Belgium, Czechia, Denmark, Ireland, Norway, Slovakia, United Kingdom
Source: ClinicalTrials.gov record NCT01416116. Inclusion in this directory is not an endorsement.