A Phase II, double-blind, randomized, cross-over, international,multicentre study to evaluate the analgesic efficacy of 3 weeks oraladministration of AZD4282 300 mg b.i.d. compared with placebo inpostherpetic neuralgia

Phase 1

• Conditions: Diagnosis of postherpetic neuralgia

• Registration Number: EUCTR2004-004908-21-DK
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01-25
• Last Update Posted: 3 October 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified