None listed
Conditions
Brief summary
The aim of this study is to evaluate the clinical efficacy and safety of Norspan (registered trademark)(Buprenorphine Transdermal Delivery System, BTDS) in reducing neuropathic pain in patients with Postherpetic Neuralglia (PHN) compared with those on a placebo patch.
Interventions
Buprenorphine Transdermal Delivery System (patch applied to the skin), 5, 10, 20, 30, 40 micrograms per hour.
Duration of treatment: maximum of 21 weeks
Sponsors
Mundipharma Pty Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients of either gender aged 18 years or older. 2. History of ongoing pain due to PHN of at least three months duration following initial Acute Herpes Zoster (AHZ) infection and rash healing, with pain intensity at screening visit of at least moderate intensity (NRS = 4/10). 3. Willingness to discontinue any current weak opioid analgesics (codeine-containing, propoxyphene-containing or tramadol) and any topical PHN therapies. 4. Patients receiving non-opioid adjuvant analgesic medications (e.g. antidepressants, AEDs, mexiletine, clonidine) or NSAIDs / COX-2 inhibitors must have a documented history of stable use over the previous three weeks with agreement to continue at a stable dosage for the duration of the trial. 5. Patients willing and able to participate in all aspects of the study, including initial medication weaning and cessation (if applicable), use of medication, completion of subjective evaluations, attending scheduled clinic visits, completing telephone contacts and patient diary, and compliance with protocol requirements as evidenced by providing written, informed consent.
Exclusion criteria
1.Previous or current treatment with Buprenorphine Transdermal System (BTDS)for Post Herpetic Neuralgia (PHN). 2. Patients treated, either currently or previously for PHN, with any strong opioid analgesic. (e.g. oxycodone, morphine, hydromorphone, fentanyl, methadone). 3. Patients currently treated with any strong opioid analgesic for any indication (e.g. oxycodone, morphine, hydromorphone, fentanyl, methadone). 4. Patients who have undergone somatic or sympathetic nerve blockade or other interventional therapies for PHN within the previous two months, or who have previously undergone neurolytic / neurosurgical treatment for PHN. 5. Patients treated with any analgesics within the last 12-hours prior to the randomisation visit, other than a] NSAIDs or adjuvant analgesic medications with dose/frequency stable for at least 3-weeks prior to study entry and continued at the stable dose/frequency for the duration of the study, and b] aspirin for cardiovascular or cerebrovascular indications up to a maximum dose of 300mg daily. 6. Hypersensitivity to opioid analgesics, transdermal delivery systems or patch adhesive such that involvement in the study would be inadvisable in the opinion of the Investigator. 7. Known intolerance to buprenorphine (e.g. Norspan, Temgesic) and/or paracetamol. 8. Use of a Monoamine Oxidase Inhibitor (MAOI) within the last 14 days. 9. History of alcohol abuse or prescription or non-prescription drug abuse or addiction. 10. Significant pain of alternative aetiology. 11. Evidence of clinically significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, neurological or psychiatric disease, as determined by medical history, clinical laboratory tests, Electrocardiogram (ECG) results, and physical examination, that would place the patient at risk upon exposure to the study medication or that may confound the analysis and/or interpretation of the study results. 12. Patients with clinically unstable cardiac disease including: unstable atrial fibrillation, symptomatic bradycardia, unstable cardiac failure, or active myocardial ischaemia. 13. Patients with a history of long QT syndrome (or an immediate family member with this condition), or with QT prolongation on initial screening ECGs (QTc = 480 milliseconds), or who have hypokalaemia on initial laboratory testing (as defined by testing laboratory), or patients currently receiving Class Ia antiarrhythmic medications (eg quinidine, mexiletine, procainamide) or Class III antiarrhythmic medications (e.g. sotalol, amiodarone). 14. Patients with evidence of significant impairment of liver function (values = 3 times upper limit of normal for Aspartate transaminase (AST) or Alanine transaminase (ALT)), or in the Investigator’s opinion, liver function impairment to the extent that the patient should not participate in the study. 15. Patients receiving hypnotics or other central nervous system (CNS) depressants that, in the Investigator’s opinion, may pose a clinically significant risk of additional CNS depression with opioid study medication. 16. Patients who have been administered a study drug in a clinical study within within 30 days of study entry (defined as the start of the Screening Period). 17.PRN use of Benzodiazepines other than a nocturnal dose for sleep. 18. Patients likely to receive any additional treatment which may interfere with study design or interfere with involvement in study. 19. Patients who have an ongoing requirement for treatment with direct external heat sources which may potentially interfere with the BTDS. 20. Patients with a dermatological disorder at any relevant patch application site that precludes proper placement and/or rotation of the patch, or with a history of eczema or cutaneous atrophy. 21. Patients unwilling or unable to give informed consent. 22. Pregnant or lactating women or women of childbearing potential not using effective contraception.
Outcome results
None listed