Status:
COMPLETED
Method of Pre-treatment for Application of QUTENZA Capsaicin 8% Patch
Lead Sponsor:
Astellas Pharma Inc
Conditions:
or Peripheral Nerve Injury (PNI)
Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN)
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
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 wh...
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 table...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 6 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2012
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT01416116
Start Date
July 6 2011
End Date
April 25 2012
Last Update
April 23 2018
Active Locations (20)
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1
Site 102
Antwerp, Belgium
2
Site 103
Genk, Belgium
3
Site 101
Roeselare, Belgium
4
Site 202
Hradec Králové, Czechia