ELEVATE
Research type
Research Study
Full title
QUTENZA versus pregabalin in subjects with peripheral neuropathic pain: an open-label, randomized, multicenter, noninferiority efficacy and tolerability study
IRAS ID
101753
Contact name
Bernhard Frank
Contact email
Sponsor organisation
Astellas Pharma Ltd
Eudract number
2011-005872-41
Research summary
This is a multicenter, randomized, open-label study which aims to compare two treatments for neuropathic pain (nerve pain) and their ability to relieve pain, their safety and their effect on general health status. This is a study of a single application of a topical patch treatment (Qutenza) versus a daily oral treatment (pregabalin) 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 nerve injuries following an operation or an accident resulting in PNP and those with other causes of PNP such as that following treatment with certain medicines. The PNP treatment will be either a patch to be placed on the skin over the painful area or capsules taken by mouth. The patch contains a substance called capsaicin which is the chemical that makes chillies taste hot. The capsules will contain a medicine called pregabalin. The reason for the study is to compare the newer treatment with pregabalin, the "gold-standard" treatment. The study is being conducted in Europe and in up to 6 hospital sites in England and Scotland. Patients will be in the study for about 9 weeks. After a screening period treatment will either be applied in the hospital clinic by trained specialists (the patch) or initiated (the capsules). Patients will be followed up in the clinic after 2, 4 and 8 weeks. Patients will also be contacted at home by telephone to review their treatment and condition. Patients will complete questionnaires to assess their quality of life. All patients will receive an active treatment.
REC name
North West - Haydock Research Ethics Committee
REC reference
12/NW/0209
Date of REC Opinion
18 Apr 2012
REC opinion
Further Information Favourable Opinion