Documented diagnosis at the Treatment Visit of either: •PHN with pain persisting at least 3 months since shingles vesicle crusting, or •Post-traumatic Peripheral Neuropathic Pain syndrome, including post-surgical neuropathic pain and neuropathic pain due to peripheral nerve injury, persisting for a minimum of 3 months following the traumatic event MedDRA version: 13.1 Level: LLT Classification code 10054095 Term: Neuropathic pain System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Qutenza (TM)
Product Name: Qutenza
Product Code: N/A
Pharmaceutical Form: Medicated plaster
INN or Proposed INN: CAPSAICIN
CAS Number: 404-86-4
Current Sponsor code: N/A
Other descriptive
Sponsors
Astellas Pharma Europe Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female between 18 and 90 years of age, inclusive 2. In good health as determined by the investigator 3. Documented diagnosis at the Treatment Visit of either: - PHN with pain persisting at least 3 months since shingles vesicle crusting, or - Post-traumatic Peripheral Neuropathic Pain syndrome, including post-surgical neuropathic pain and neuropathic pain due to peripheral nerve injury, persisting for a minimum of 3 months following the traumatic event 4. NPRS score = 4 for average pain both at the Screening Visit and at the Treatment Visit 5. Intact, non-irritated, dry skin over the painful area(s) to be treated 6. Females of child bearing potential must be willing to use effective methods of birth control during the study and for 30 days following study termination 7. Willing and able to comply with protocol requirements for the duration of study participation 8. Written informed consent has been obtained (Reference is made to the protocol) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Significant ongoing or recurrent pain of aetiology other than PHN or post-traumatic peripheral neuropathy, for example; compression-related neuropathies (e.g. spinal stenosis), mixed pain, fibromyalgia or arthritis 2. Pain due to Complex Regional Pain Syndrome (CRPS, Type I) 3. Neuropathic pain areas located only on the face, above the hairline of the scalp, on the feet, and/or in proximity to mucous membranes 4. Neuropathic pain areas located only on the feet 5. Past or current history of Type I or Type II diabetes mellitus 6. Active malignancy or treatment for malignancy during the past year (including radiotherapy, chemotherapy and biologic or hormonal therapies). A history of squamous cell carcinoma or a basal cell carcinoma not involving the area to be treated is allowed. 7. Clinically significant cardiovascular disease within 6 months prior to screening visit defined as cerebrovascular accident, unstable or poorly controlled hypertension, transient ischemic attack, myocardial infarction, unstable angina, current arrhythmia, any heart surgery including coronary artery bypass graft surgery, percutaneous coronary angioplasty/stent placement, or valvular heart disease 8. Clinically significant abnormal ECG at screening 9. Significant ongoing or untreated abnormalities in cardiac, renal, hepatic, or pulmonary function that may interfere either with the ability to complete the study or the evaluation of AEs 10. Uncontrolled epilepsy or risk of convulsions 11. Diagnosis of any major psychiatric disorder 12. Evidence of cognitive impairment including dementia that may interfere with subject’s ability to complete study evaluations and recall pain levels in the past 24 hours 13. Planned elective surgery during the trial 14. Any prior treatment with QUTENZA patches, including blinded patches administered as part of a clinical trial 15. Hypersensitivity to capsaicin (i.e., chilli peppers or over-the-counter [OTC] capsaicin products), any QUTENZA excipients or adhesives, local anesthetics, tramadol, or any tramadol excipients 16. Treatment with opioids (including tramadol) within 7 days preceding the Treatment Visit. 17. Unwillingness to use opioid analgesics during study treatment, or high tolerance to opioids precluding the ability to relieve treatment-associated discomfort with oral or parental opioids, as judged by the investigator 18. Treatment with carbamazepine or MAO-inhibitors or within 2 weeks of withdrawal from treatment with MAO-inhibitors at the Treatment Visit 19. Use of any topical pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics (including patch containing lidocaine), steroids or capsaicin products on the painful areas within 7 days preceding the Treatment Visit 20. Participation in any other clinical study or receipt of an investigational drug within 30 days prior to Screening Visit 21. Active substance abuse or 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 22. Subject, who in the opinion of the investigator, is not likely to complete the study for any reason (Reference is made to the protocol)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the tolerability of QUTENZA treatment when applied after pre-treatment with topical lidocaine or oral tramadol. ;Secondary Objective: To evaluate the safety of QUTENZA treatment when applied after pre-treatment with topical lidocaine or oral tramadol.;Primary end point(s): Primary Tolerability Variable • Proportion of subjects who tolerate QUTENZA treatment. A QUTENZA tolerant subject is defined as a subject receiving at least 90% of the intended patch duration. For the 60 minute application, this means at least a 54 minute exposure. (Reference is made to the protocol) | — |
Countries
Belgium, Czech Republic, Denmark, Ireland, Slovakia, United Kingdom
Outcome results
None listed