Efficacy of capsaicin 8% patches in Pulmonary Arterial Hypertension

• Research type

  Research Study

• Full title

  A double-blinded, randomized, crossover clinical study to assess the efficacy of Qutenza (capsaicin 8% patches) for the reduction of site pain caused by continuous subcutaneous infusion of Remodulin (treprostinil sodium), in Pulmonary Arterial Hypertension Patients

• IRAS ID

  69361

• Contact name

  Vincenzo Libri

• Eudract number

  2011-001312-59

• ISRCTN Number

  0000000000000

• Clinicaltrials.gov Identifier

  0000000000000

• Research summary

  Pulmonary arterial hypertension (PAH) is a rare life-threatening disease characterised by high blood pressure in the lung arteries eventually leading to right ventricular failure and death. Several medicinal products have been approved for the treatment of PAH. Among others, Remodulin© (treprostinil sodium) via infusion improves exercise tolerance and other symptoms. However, the drug causes some adverse effects including severe local regional pain. Conventional pain remedies are not very effective in controlling Remodulin©-induced pain.Qutenza© patch is a new treatment option that has been recently approved for the management of pain associated with post-herpetic neuralgia. Qutenza© contains synthetic capsaicin (8%), a substance naturally present in chilli peppers that can desensitise nerve terminals in the skin so that they no longer respond to the stimuli that normally cause pain. A single, 1-hour application of Qutenza can provide long lasting pain relief (up to 3 months) with maximum effects reached within 1-2 weeks from the application.The present study will explore the efficacy of single applications of Qutenza© in reducing site pain caused by continuous subcutaneous infusion of Remodulin©in PAH patients, as assessed by changes in subjective patient global impression of change and pain rating score at the site of Remodulin© infusion, as well as objective pain and sensory testing measuring changes in cutaneous hypersensitivity and skin flare around the infusion site.Twelve male and female PAH patients (WHO class II-IV) will be enrolled to provide evaluable data from a minimum of eight patients completing two treatment periods, during which they will receive Qutenza© or control patches containing no medication. The study will be double-blinded so patients and investigators will not known the order in which active and control patches will be applied.The study involves a maximum of 8 visits and is expected to be completed within 6-8 months from start.

• REC name

  Wales REC 3

• REC reference

  11/WA/0083

• Date of REC Opinion

  24 Jun 2011

• REC opinion

  Further Information Favourable Opinion