Observation of the Use of QUTENZA™ in Standard Clinical Practice

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This non-interventional study will evaluate the efficacy, tolerability, health related quality of life and use of health resources associated with QUTENZA treatment when QUTENZA is used in standard clinical practice.

The patient's primary diagnosis of peripheral neuropathic pain (PNP) will be classified into subtypes: post-herpetic neuralgia (PHN); HIV-associated neuropathy (HIV-AN); neuropathic back pain; cancer-related neuropathic pain; post-operative & post-traumatic neuropathic pain; and 'other' neuropathies.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Europe Ltd.
• Treatments: Capsaicin

Criteria

Inclusion Criteria:

• 1. The investigator has decided to treat the patient with QUTENZA as part of provision of standard care for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain

• 2. The patient is willing and able to comply with protocol requirements for the duration of study participation

Exclusion Criteria:

• 1. The neuropathic painful areas are located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes

• 2. The patient has a history of Type I or Type II diabetes mellitus

• 3. The patient has a diagnosis of any major psychiatric disorder or evidence of cognitive impairment including dementia that, in the opinion of the investigator, may interfere with patient's ability to complete study evaluations

• 4. The patient has received any prior treatment with QUTENZA patches, including blinded patches administered as part of a clinical trial

• 5. The patient has hypersensitivity to capsaicin (i.e. chilli peppers or over-the-counter [OTC] capsaicin products), any QUTENZA excipients or adhesives, or local anesthetics

• 6. The patient has participated in any other clinical study or received an investigational drug within 30 days prior to Screening Visit

• 7. The patient currently engages in any active substance abuse or has a history of chronic substance abuse within 1 year prior to the Screening Visit; or any prior chronic substance abuse (including alcoholism) likely to re-occur during the study period as judged by the investigator

• 8. The patient, in the opinion of the investigator, is not suitable to participate in this NIS for any reason