NCT01713426

A Study to Compare QUTENZA With Pregabalin for the Treatment of Peripheral Neuropathic Pain (PNP) After 8 Weeks of Treatment

Qutenza Versus Pregabalin in Subjects With Peripheral Neuropathic Pain: an Open-label, Randomized, Multicenter, Non-inferiority Efficacy and Tolerability Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 568 (actual)
• Sponsor: Astellas Pharma Europe Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is comparing the efficacy and tolerability of Qutenza with that of pregabalin in patients suffering from peripheral neuropathic pain. Treatment allocation will be to one of these treatments and the duration of the study will be about 10 weeks (assuming that from screening to treatment allocation takes 2 weeks). Participants will be asked to complete questionnaires about various aspects relating to their condition throughout the study. This study will include subjects suffering from Postherpetic Neuralgia, Peripheral Nerve Injury or Non Diabetic peripheral polyneuropathy.

Conditions

• Non-diabetic Painful Peripheral Polyneuropathy
• Postherpetic Neuralgia (PHN)
• Peripheral Nerve Injury (PNI)

Interventions

Type	Name	Description
DRUG	Qutenza	Cutaneous patch
DRUG	Pregabalin	Oral capsule

Timeline

• Start date: 2012-07-11
• Primary completion: 2013-09-26
• Completion: 2013-09-26
• First posted: 2012-10-24
• Last updated: 2018-04-23

Locations

98 sites across 22 countries: Armenia, Austria, Belarus, Belgium, Bulgaria, Czechia, Finland, France, Germany, Greece, Hungary, Italy, Poland, Portugal, Romania, Russia, Slovakia, Slovenia, Spain, Sweden, Turkey (Türkiye), United Kingdom