STRIDE
Research type
Research Study
Full title
A Multicentre, Single-Arm, Open-Label Study Of The Repeated Administration Of QUTENZA For The Treatment Of Peripheral Neuropathic Pain
IRAS ID
54880
Contact name
Graeme Moyle
Sponsor organisation
Astellas Pharma Europe Ltd
Eudract number
2009-016457-18
ISRCTN Number
No number provided
Clinicaltrials.gov Identifier
No number provided
Research summary
This is a single-arm, long-term study of repeated applications of a new topical treatment for patients with "peripheral neuropathic pain" or PNP for short. Patients with this condition to be treated can be those with post-herpetic pain (something some people get following shingles), those with HIV (the virus responsible for AIDS), or those with nerve injuries resulting in PNP. The reason for the study is mainly to check that repeated treatments over a year do not cause problems not detected in the studies already completed. The treatment is a patch to be placed on the skin over the painful area. The patch contains a substance called capsaicin which is the chemical that makes chillies taste hot. The study is being conducted in Europe and in eight hospital sites in England and Scotland. Patients will receive treatment at the start of the study and can have up to 6 treatments over the course of the year if required due to their pain coming back. Pain relief after one patch lasts about 12 weeks and patients may be re-treated very 12-9 weeks. Treatment is applied in the hospital clinic by trained specialists and a visit for treatment and assessments of pain and quality of life may last about 4 hours. All patients receive the active treatment and apart from taking and making telephone calls between visits to the clinic (to discuss pain levels and quality of life) no changes to life-style are required.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
10/H1107/42
Date of REC Opinion
2 Sep 2010
REC opinion
Further Information Favourable Opinion