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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
306
Cutaneous patch
Adverse events (AEs)
Time frame: Throughout the study up to 65 weeks
Serious adverse events (SAEs)
Time frame: Throughout the study up to 65 weeks
Treatment-emergent adverse events
Time frame: Throughout the study up to 65 weeks
Proportion of subjects who prematurely terminate from the study due to an AE
Time frame: Throughout the study up to 65 weeks
Change in Sensory function
Time frame: All visits throughout the study up to 65 weeks
Use of concomitant pain medications following each patch application
Time frame: Throughout the study up to 65 weeks
Change from baseline in Vital signs
Time frame: All visits throughout the study up to 65 weeks
Dermal assessment score
Time frame: All visits throughout the study up to 65 weeks
The proportion of subjects completing at least 90% of the intended patch application duration
Time frame: All visits throughout the study up to 65 weeks
Neurological assessment
Time frame: All visits throughout the study up to 65 weeks
Brief Pain Inventory (BPI)
Time frame: Throughout the study up to 65 weeks
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Unnamed facility
Vienna, Austria
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Vienna, Austria
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Antwerp, Belgium
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Brussels, Belgium
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Edegem, Belgium
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Genk, Belgium
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Roeselare, Belgium
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Brno-Bohunice, Czechia
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Plzen-Lochotin, Czechia
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Prague, Czechia
...and 54 more locations
Patient Global Impression of Change (PGIC)
Time frame: All visits throughout the study except the first patch application visit up to 65 weeks
European Quality of life questionnaire in 5 Dimensions (EQ5D)
Time frame: All visits throughout the study except the screening visit and unscheduled visits up to 65 weeks
Hospital Anxiety and Depression Score (HADS)
Time frame: All visits throughout the study except the screening visit and unscheduled visits up to 65 weeks
Work Productivity and Activity Impairment Questionnaire: Neuropathic Pain (WPAI:NP)
Time frame: All visits throughout the study except the screening visit and unscheduled visits up to 65 weeks
Self-Assessment of Treatment (SAT) questionnaire
Time frame: At the Week 26 visit and planned or early termination visit no later than week 65
Change in use of concomitant pain medications
Time frame: Throughout the study up to 65 weeks