NCT01252160

Safety and Effectiveness of Repeated Administration of QUTENZA Patches for Treatment of Pain Caused by Nerve Damage

A Multicentre, Single-Arm, Open-Label Study Of The Repeated Administration Of QUTENZA For The Treatment Of Peripheral Neuropathic Pain

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 306 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

In this study all patients will be treated with the same medicine, the QUTENZA patch. Subjects will receive up to 6 QUTENZA patch applications over 12 months.

Detailed description

The rationale for the current study is to evaluate the safety of repeated QUTENZA applications, including the effect of QUTENZA on sensory function in subjects diagnosed with different types of Peripheral Neuropathic Pain (PNP). In order to adequately assess the long-term safety QUTENZA in well defined patient populations the current study will enroll a minimum of 100 patients each with HIV-Associated Neuropathy (HIV-AN) and Postherpetic Neuralgia (PHN).

Conditions

• Neuralgia, Postherpetic

Interventions

Type	Name	Description
DRUG	QUTENZA	Cutaneous patch

Timeline

• Start date: 2010-10-28
• Primary completion: 2013-09-26
• Completion: 2013-09-26
• First posted: 2010-12-02
• Last updated: 2018-04-19

Locations

64 sites across 16 countries: Austria, Belgium, Czechia, Finland, France, Greece, Hungary, Ireland, Italy, Netherlands, Poland, Romania, Slovakia, Slovenia, Spain, United Kingdom