Post-surgical neuropathic pain MedDRA version: 14.1 Level: LLT Classification code 10054095 Term: Neuropathic pain 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 who underwent surgery at least 3 months before inclusion in the study 3.Patients with Dolour Neuropathique 4 (DN4) score ? 4 4.Location of pain, allodynia and hyperalgesia consistent with surgical area 5.Patients at screening visit must have a moderate to severe pain intensity measured by a score ? 4 on the Numerical Pain Rating Scale (NPRS) 6.Patients must have a moderate to severe pain intensity (i.e., a mean score ? 4 on the NPRS) during 7 days prior to the Visit 2, (Day -1). Patients must record at least five assessments of the 24-hour average daily pain intensity score during the seven-day run-in period 7.Patients who provide a signed informed consent prior to study entry 8.Subjects must agree to use acceptable methods of contraception 9.Willingness to understand and comply with protocol requirements for the duration 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 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
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 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 ?tricyclic, selective serotonin reuptake inhibitor (SSRI) or serotonin and noradrenalin reuptake inhibitor (SNRI) antidepressants ?NMDA antagonists ?Thalidomide ?Nitrous oxide ?Ca++/Mg++ infusions 8.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. 9.History of drug abuse or dependence (drug categories defined by Diagnostic and Statistical Manual of Mental Disorders [DSM IV]) within the past year, excluding nicotine and caffeine. 10.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. 11.History of severe gastroparesis or gastric bypass surgery. 12.Previous neurolytic or neurosurgical treatment for the studied neuropathic pain. 13.Injected anesthetics or steroid use within 30 days of Visit 1. 14.Active malignancy within the month previous to the inclusion in the study, with the exception of non-melanoma skin cancers. 15.Has a known history of a positive human Immunodeficiency Virus (HIV) antibody test or known HIV infection 16.Has a known history of positive Hepatitis B or C virus serology indicative of active acute or chronic infection 17.Unable to comply with the study procedures 18.Patients with the following laboratory values abnormalities: ?Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and gammaglutamil trnspeptidase (GGT) > 2 x ULN (Upper Limit Normality) ?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: To assess the analgesic efficacy of repeated doses of E-52862 in subjects with moderate to severe post-surgical neuropathic pain;Secondary Objective: To describe the safety and tolerability profile of E-52862 when administered during 28 days to patients with moderate to severe post-surgical neuropathic pain. 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 post-surgical peripheral neuropathic pain;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 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 24 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety ? 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