Postherpetic Neuralgia MedDRA version: 14.1 Level: PT Classification code 10036376 Term: Post herpetic neuralgia System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
Laboratorios del Dr. Esteve. S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female ? 18 2.Patients with Herpes Zoster (HZ) with pain persistent at least one month but less than 3 months after the rash onset. 3.Patients at screening visit must have a moderate to severe pain intensity measured by a score ? 4 on the NPRS 4.Patients who provide a signed informed consent prior to study entry 5.Subjects must agree to use acceptable methods of contraception 6.Be willing and able to understand and comply with protocol requirements for the durations of study participation 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: 1.Pregnant or nursing women 2.Patients having severe pain related to other causes 3.Exposure in the previous 30 days to drugs known to cause neuropathy (as described in section 6.2.2 Prohibited medication) 4.Major psychiatric disorder 5.Serious or unstable cardiovascular disease that could compromise participation or cause hospitalization during the study 6.Second or third degree atrioventricular blockade not corrected with a pacemaker or any clinically significant abnormality in the 12 lead electrocardiogram as determined by the investigator 7.Subjects taking the following drug classes and individual drugs which cannot discontinue their use, are excluded: -benzodiazepines (except short half-life sleep agents) -skeletal muscle relaxants -orally administered steroids -centrally acting analgesics (dextromethorphan, tramadol) -opiates -topical lidocaine or capsaicin -NSAID -Anticonvulsants other than gabapentin and pregabalin -tricyclic, selective serotonin reuptake inhibitor (SSRI) or serotonin and noradrenalin reuptake inhibitor (SNRI) antidepressants -NMDA antagonists -Thalidomide -Nitrous oxide -Ca++/Mg++ infusions In case of discontinuation, these drugs require a minimum washout period of at least 5 times the half life and should be tapered appropriately using product label instructions as a guide before the patient enters the run in period of the study 8.Subjects taking gabapentin or pregabalin for which the dosage has been changed within the month previous to the screening visit. 9.History of any active serious medical conditions that, in the investigator's opinion, can compromise the subject's safety or interfere with the study assessments. 10.History of drug abuse or dependence (drug categories defined by DSM IV) within the past year, excluding nicotine and caffeine. 11.Subjects who, in the previous 30 days, received treatment with a drug that had not received regulatory approval for any indication at the time of study entry. 12.History of severe gastroparesis or gastric bypass surgery. 13.Previous neurolytic or neurosurgical treatment for the studied neuropathic pain. 14.Injected anesthetics or steroid use within 30 days of Visit 1. 15.Malignancy within past 2 years. 16.Has a known history of a positive (HIV) antibody test or known HIV infection 17.Has a known history of positive Hepatitis B or C virus serology indicative of active acute or chronic infection 18.Unable to comply with the study procedures 19.Patients with the following laboratory values abnormalities: -ALT, AST and GGT > 2 x ULN -Neutrophils 1.25 X ULN -Creatinine clearance according to the Cockroft-Gault equation: ? 70 mL/min -Any other laboratory abnormality that is judged by the investigator to be clinically relevant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the analgesic efficacy of E-52862 in subjects with moderate to severe postherpetic neuralgia;Secondary Objective: To describe the safety and tolerability profile of E-52862 when administered during 28 days to patients with moderate to severe postherpetic neuralgia. To assess E-52862 plasma exposure associated with a pharmacodynamic response after administration of repeated oral doses for 28 days in patients with moderate to severe postherpetic neuralgia.;Primary end point(s): Efficacy ? Time specific change from baseline to day 28 in mean pain intensity in the previous 7 days interval measured by a Numerical Pain Rating Scale (NPRS) included in a patient diary (average and worst 24 hour pain included in the short form of the Brief Pain Inventory [SF-BPI]) ? 50%-responder rates at day 7, 14, 21 and 28, defined as the proportion of patients with a reduction from baseline of at least 50% of the mean 24 hour average pain score in the previous 7 days (measured by a NPRS included in a patient diary) ? 30%-responder rates at day 7, 14, 21 and 28, defined as the proportion of patients with a reduction from baseline of at least 30% of the mean 24 hour average pain score in the previous 7 days (measured by a NPRS included in a patient diary) ? Time specific change from baseline to day 7, 14 and 21 in mean pain intensity in the corresponding previous 7 days measured by a NPRS included in a patient diary (average and worst 24h hour pain) ? Time to onset of sustained therapeutic improvement, defined as first day on which patients demonstrated a ?1-point reduction in mean pain NPRS score from baseline in patients with a ?30 and ?50% reduction in mean pain score at day 28 ? Percentage of subjects needing rescue medication and amount of rescue medication used ? Change from baseline to day 28 in short form of McGill Pain Questionnaire (SF-MPQ) ? Change from baseline to day 7, 14, 21 and 28 in SF-BPI ? Change from basel | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety ? Adverse Events (AEs) reported ? The percentage of patients reporting one or more AEs ? Laboratory tests at screening visit and Day 28 (+ follow up tests if necessary) ? Vital signs and ECG findings at each visit;Timepoint(s) of evaluation of this end point: 28 days | — |
Countries
Spain
Contacts
Public ContactStudy Medical Monitor
Laboratorios del Dr. Esteve. S.A.
Outcome results
None listed