Patients with Posttraumatic Neuralgia (PTN) and Postherpetic Neuralgia (PHN) Intended Indication is Neuropathic Pain MedDRA version: 9.1 Level: LLT Classification code 10029223 Term: Neuralgia
Conditions
Interventions
Product Name: AZD1386
Product Code: AZD1386 30 mg
Pharmaceutical Form: Capsule, hard
Current Sponsor code: AZD1386 hydrogen sulphate
Concentration unit: mg milligram(s)
Concentration type: equal
Conce
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Provision of informed consent prior to any study specific procedures 2.Male or female patients =18 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Other pain conditions that may confound assessment of neuropathic pain, as judged by the investigator 2. Central neuropathic pain conditions such as associated with stroke, multiple sclerosis, or spinal cord injury 3. Any prior treatment of neuropathic pain with neurolytic therapy, intrathecal pump, spinal cord stimulator or neurosurgery 4. History, and/or presence, of somatic disease/condition, which may interfere with the objectives of the study as judged by the investigator 5. Diagnosis of any severe neurological disease (e.g. epilepsy, MS, Parkinson´s disease, neurodegenerative disease) as judged by the investigator 6. Malabsorption, gastrointestinal disorder or surgery leading to impaired drug absorption 7. History of malignancy, treated or untreated, within the past 5 years, with the exception of successfully treated basal cell or squamous cell carcinoma of the skin 8. Risk factors for ventricular fibrillation (e.g. family history of Short QT syndrome (SQTS) or sudden cardiac death (SCD) amongst first-degree relatives 9. QTcF interval 450 msec at enrolment 10. A recent history (in the past 3 months) suggestive of alcohol or drug abuse or dependence, including overuse/abuse of narcotics for management of pain 11. Enrolment laboratory value for ALT, AST >2 times the upper limit of normal range 12. Positive test result for hepatitis B surfactant antigen (HbsAg) or hepatitis C antibody 13. Known or suspected human immunodeficiency virus (HIV) infection, as judged by the investigator 14. Clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator 15. Use of any prohibited medication at V2 16. History of treatment failure with = 3 adequate trials of medication used to treat neuropathic pain. Failure could be insufficient efficacy or discontinuation due to side effects. 17. History of significant psychiatric disease/disorder that could preclude reliable participation in the study in the judgement of the investigator. Subjects with a diagnosis of depression who are in remission for at least 12 weeks before enrolment with or without stable selective serotonin reuptake inhibitor (SSRI) treatment are allowed in the study. 18. Patients involved in processes regarding monetary compensation due to the condition under study (e.g. insurance issues). 19. Breast-feeding women 20. Positive pregnancy test 21. Donation of plasma within the two weeks prior to the enrolment visit and/or donation of blood within the three months prior to the enrolment visit and during the study 22. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) 23. Participation in other clinical trial, use of any investigational drugs or procedures or use of experimental medications within 30 days prior to the enrolment visit 24. According to the investigator the patient should not participate in the study 25. Clinically significant illness within two weeks before the administration of the investigational product, as judged by the investigator 26. Patients with a cognitive disorder which would impair cooperation with study procedures, as judged by the investigator 27. Previous randomisation in the present study 28. A history of symptoms of hypersensitivity reactions (such as asthma, rhinitis or urticaria) or contraindications to paracetamol/acetaminophen 29. Positive urine drugs of abuse screen including cannabis, cocaine, heroin/m
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the analgesic efficacy of 21 days of oral administration of AZD1386 compared to placebo in patients with Post Traumatic Neuralgia (PTN) or Post Herpetic Neuralgia (PHN) with mechanical hypersensitivity;Secondary Objective: 1. To evaluate the response rate of patients to AZD1386 versus placebo. 2. To evaluate the effect of AZD1386 on different components of pain compared to placebo. 3. To evaluate the effect of AZD1386 on different descriptors of pain compared to placebo. ;Primary end point(s): Change from baseline in NRS pain (12 h-recall), morning and evening measurement | — |
Countries
Denmark, France, United Kingdom
Outcome results
None listed