Diagnosis of postherpetic neuralgia
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent. 2. Be able to understand and comply with the requirements of the study. 3. Female or male subjects 18-80 years of age. 4. Female subjects must be post-menopausal by at least 2 years or surgically sterile. 5. Diagnosis of postherpetic neuralgia, i.e. history of acute herpes zoster with pain persisting in the affected skin area at least 6 months after resolution of skin rash. 6. Mean pain intensity =40 on 100 mm VAS during baseline week, based on recordings of average pain intensity last 24 hours. All inclusion criteria, except no 6, must be fulfilled at visit 1. All inclusion criteria must be fulfilled at visit 2. 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.Other pain that may confound assessment of pain attributed to postherpetic neuralgia, as judged by the investigator. 2.Subjects that have been treated with neurolytic procedures (chemical or surgical nerve lesioning) for postherpetic neuralgia. 3.Severe, unstable or insufficiently treated hypertension, cardiovascular, cerebrovascular or peripheral vascular disease, as judged by the investigator. 4.Diabetes Mellitus requiring pharmacological treatment (insulin, antidiabetics), or, with any organ complication. 5.Diagnosis or history of any severe neurological disease (e.g. epilepsy, MS, Parkinson´s disease, neurodegenerative disease), as judged by the investigator. 6.History of alcohol or drug abuse within the last 2 years. 7.Any other serious or unstable medical or psychiatric condition, as judged by the investigator (e.g. HIV, organ transplanted subjects, malignancy treatment). 8.S-Creatinine above 106 µmol/L. Any AZ standard laboratory test value outside AZ extended reference range (S-Bilirubin, S-ASAT, S-ALAT, S-Alkaline Phosphatase, S-Creatinine, S-Albumin, S-Potassium, S-Calcium, S-Sodium, B-Hemoglobin, (B-Hb), B-Leucocyte Particle Concentration (B-LPC; including B-differential count: lymphocytes, monocytes, neutrophiles, eosinophiles, and basophiles, B-Platelet Particle count and dipstick test for U-Glucose, U-Protein, U-Hemoglobin (U-Hb), U-Leucocytes. 9.Treatment with opioids (other than tramadol as rescue medication), cannabinoids, any antidepressants, anticonvulsants, or antiarrythmics from 3 weeks before visit 1 (screening visit) until the last visit. 10.Treatment with topical local anaesthetics, topical capsaicin, acupuncture, nerve blockade or nerve stimulation treatments. 11.Treatment with acidic albumin bound drugs with a low safety margin, e.g. warfarin, cloxacillin, methotrexate, chloral hydrate, etacrynic acid. 12.Treatment with potentially nephrotoxic drugs, e.g. acetylsalicylic acid exceeding 160 mg daily dose, NSAIDs, COX-2-inhibitors, aminoglycosides, cefalosporins, sulfonamides, trimetoprim, lithium, cyclosporine. 13.Treatment with substrates of CYP3A4 with a low safety margin, e.g. benzodiazepines, statines, calcium-channel blockers, sildenafil, macrolide antibiotics, ergot alkaloids, quinine, cisapride, astemizole, terfenadine, eplerenone. 14.Treatment with NMDA-antagonists, e.g. ketamine, dextromethorphan, memantine. 15.Treatment with probenecide. 16.Treatment with herbal remedies that may interfere with the study interpretation, as judged by the investigator. 17.Intake of energy drinks containing taurine or glucuronolactone. 18.Donation of plasma from 2 weeks before visit 1 (screening visit), or donation of blood from 3 months before visit 1, and throughout the study. 19.A history of symptoms of hypersensitivity reactions (such as asthma, rhinitis or urticaria) or contra-indications to paracetamol/acetaminophen or tramadol. 20.Participation in another investigational drug study within 30 days prior to visit 1. 21.Previous enrolment in the present study or any other study on AZD4282. All exclusion criteria, except no 8, must not be fulfilled at visit 1. None of the exclusion criteria must be fulfilled at visit 2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the analgesic efficacy of 3 weeks oral administration of AZD4282 compared with placebo in postherpetic neuralgia.;Secondary Objective: To explore the effects of AZD4282 compared with placebo on pain relief . •To explore the effects of AZD4282 compared with placebo on interference of pain with general activity, mood and sleep. •To explore the effects of AZD4282 compared with placebo on subjects/clinicians overall rating of treatment effect. •To explore the effects of AZD4282 compared with placebo on pain and global measures in terms of proportion of responders. •To explore the effects of AZD4282 compared with placebo on consumption of rescue medication. •To evaluate the safety and tolerability of AZD4282. •To evaluate pharmacokinetics/pharmacodynamics of AZD4282. . To generate a collection of DNA samples from subjects enrolled in the main study who provide, separate, optional consent. ;Primary end point(s): The change in the mean value of all 24 hour average pain intensity recordings (every evening) from the baseline week to the last treatment week in each treatment period (eVAS). | — |
Countries
Denmark
Outcome results
None listed