PACE

• Research type

  Research Study

• Full title

  A Randomized, Controlled, Long-term Safety Study Evaluating the Effect of Repeated Applications of QUTENZATM plus Standard of Care versus Standard of Care alone in Subjects with Painful Diabetic Peripheral Neuropathy

• IRAS ID

  82035

• Sponsor organisation

  Astellas Pharma Europe B.V.

• Eudract number

  2009-016458-42

• ISRCTN Number

  NA

• Research summary

  A study using QUTENZA patches to evaluate the long-term safety of repeated applications on patients with Painful Diabetic Peripheral Neuropathy (PDPN)While clinical studies conducted to date showed that treatment with QUTENZA does not cause changes in the functioning of nerves, these studies included patients with other types of neuropathic pain. Information on the effect of QUTENZA on neurological function in patients with PDPN is limited.The information collected in this study will be processed to find out whether the treatment tested in this study is safe. Information may be used for seeking approval from the medicines regulatory authorities to market the medicine for PDPN. This is a 3-arm study of approximately equal size and patients will be randomly assigned:In the first, subjects will receive a QUTENZA patch applied for 30 minutes to the feet; in the second, patients will receive a QUTENZA patch applied for 60 minutes to the feet; the third will continue to receive their normal treatment for their neuropathic pain.Subjects in all groups will receive a telephone call on months 1, 3, 5, 7, 9 and 11. They will have a clinic visit on the alternate months. Unscheduled visits can also be arranged at any time.The following assessments will be included:Taking of medical history and listing of present medications being taken; blood pressure and pulse measured; ECG performed; blood samples taken; physical examination; completion of questionnaires.Selection criteria include: Patients must be either 18 or older; have a diagnosis of painful, distal symmetrical, sensorimotor polyneuropathy which is due to diabetes, for at least 1 year prior to the screening visit.The study is organized and funded by Astellas Pharma Europe B.V and will be monitored by Chiltern International. A total of approximately 450 subjects in 40-50 centres within Europe will take part. Patients will be involved for just over a year.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  11/NW/0443

• Date of REC Opinion

  15 Aug 2011

• REC opinion

  Further Information Favourable Opinion