The purpose of the study is to assess the safety of repeated applications of QUTENZA in reducing pain intensity in subjects who have peripheral neuropathic pain due to diabetes.
Patients will be divided into 3 groups of approximately equal size. In the first group, patients will receive a QUTENZA patch applied for 30 minutes to the feet; in the second group, patients will receive a QUTENZA patch applied for 60 minutes to the feet. In both these groups patients will also continue to receive their normal treatment (Standard of Care (SOC)) for their peripheral neuropathic pain (PNP) and may receive further QUTENZA patch applications in the same way during the study. The third group will not receive a QUTENZA patch but will continue to receive their normal treatment for their neuropathic pain (SOC). Subjects will be involved in the study for up to 15 months and will have to visit the clinic at least 9 times.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
468
A Qutenza (8% capsaicin) patch will be applied to identified painful areas for 30 minutes (Arm 1) or 60 minutes (Arm 2).
Percentage change in health related quality of life (HRQOL) total score as assessed by the disease specific Norfolk scale
Time frame: Baseline till endpoint (discontinuation or End of Study visit) (up to 64 weeks)
Neurological function as assessed by the Utah Early Neuropathy Scale (UENS) and sensory testing
Physicians measuring neurological function will be blinded to treatment
Time frame: Baseline till End of Study (up to 64 weeks)
Tolerability of patch application by dermal assessment
Time frame: Screening till Last visit when QUTENZA patch is applied (up to 53 weeks)
Tolerability of patch application by "pain now" Numeric Pain Rating Scale (NPRS) scores after patch application
Assessed within 15 minutes and 60 minutes after patch removal.
Time frame: Baseline till Last visit when QUTENZA patch is applied (up to 52 weeks)
Tolerability of patch application by rescue medication use
Time frame: Days 1 through 5 after each patch application
Adverse Events and serious adverse Events
Time frame: Screening visit through End of study visit (up to 65 weeks)
Vital Signs (heart rate and blood pressure)
In case of patch application to be performed within 15 minutes before topical anesthetic application and within 15 minutes after patch removal.
Time frame: Screening visit through End of study visit (up to 65 weeks)
Laboratory Analyses
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Site: 601
Bonheiden, Belgium
Site: 903
Beroun, Czechia
Site: 910
Brno, Czechia
Site: 908
Choceň, Czechia
Site: 911
Litoměřice, Czechia
Site: 906
Ostrava, Czechia
Site: 904
Polička, Czechia
Site: 901
Prague, Czechia
Site: 902
Přerov, Czechia
Site: 909
Rychnov nad Kněžnou, Czechia
...and 54 more locations
The tests performed at the screening visit will include Hematology: Red Blood Cell Count, White Blood Cell Count, Lymphocytes, Neutrophils, Eosinophils, Basophils, Monocytes, Hemoglobin, Hematocrit and Platelets. Biochemistry: Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (ALT), Alkaline Phosphatase, Sodium, Potassium, Blood Urea Nitrogen (BUN), Creatinine and Lipid profile. Subsequent HbA1c and lipid profile follow-up will be done at bi-monthly visits. The other tests will be performed if clinically indicated.
Time frame: Screening visit through End of study visit (up to 65 weeks)
Intensity of neuropathic pain using "average pain" NPRS scores
Question 5 of Brief Pain Inventory-Diabetic Neuropathy (BPI-DN)
Time frame: Screening visit through End of study visit (up to 65 weeks)
Brief Pain Inventory (BPI) pain severity index and pain interference index
Time frame: Screening visit through End of study visit (up to 65 weeks)
Patient Global Impression of Change
Time frame: After each patch re-application, from first patch re-application through End of Study visit (up to 56 weeks)
Generic HRQOL measured by European Quality of Life - 5 Dimensions (EQ-5D) questionnaire
Time frame: After each patch application, from first patch application through End of Study (up to 64 weeks)
Treatment satisfaction using the Self-Assessment of Treatment (SAT) questionnaire at week 12/End Of Study visit
Time frame: End of Study (up to 65 weeks)