painful diabetic neuropathy MedDRA version: 14.1 Level: LLT Classification code 10067547 Term: Diabetic peripheral 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 years of age 2. Pain due to polyneuropathy caused by type 1 or type 2 diabetes mellitus. Pain must be present for a minimum of 6 months, but less than 5 years 3. Pain began in the feet with relatively symmetrical onset 4. Painful diabetic neuropathy diagnosis confirmed by a score of at least 3 on the Michigan Neuropathy Screening Instrument (MNSI) 5. Patients at screening visit must have a moderate to severe pain intensity measured by a score ? 4 on the 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 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 with glycosylated haemoglobin A1c of ? 10.0% at screening 8. Patients with stable diabetes treatment within the last month with no anticipated changes in medication regimen 9. Patients who provide a signed informed consent prior to study entry 10. Subjects must agree to use acceptable methods of contraception (see section 5.1) 11. 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 with conditions that might interfere with the assessment of the PDN such as peripheral vascular disease, neurological disorders unrelated to diabetic neuropathy, skin condition in the area of the neuropathy that could alter sensation or other painful conditions. 3. Patients having severe pain related to other causes 4. Exposure in the previous 30 days to drugs known to cause neuropathy (as described in section 6.2.2 Prohibited medication) 5. Major psychiatric disorder 6. Serious or unstable cardiovascular disease that could compromise participation or cause hospitalization during the study 7. Second or third degree atrioventricular blockade not corrected with a pacemaker or any clinically significant abnormality in the 12 lead ECG as determined by the investigator 8. 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 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 inclusion in the study 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 anaesthetics 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 |
|---|---|
| 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 baseline to day 7, 14, 21 and 28 in Neuropathic Pain Symptom Inventory (NPSI) ? Change from baseline to day 7, 14, 21 and 28 in allodynia and hyperalgesia, measured by VAS after stimulus (brushing and pinprick) ? Assessment of post-treatment pain by measurement of efficacy endpoints at day 35 ? Change from baseline to day 28 in SF-36 ? Patient Global Impression of Change at day 28;Timepoint(s) of evaluation of this end point: 28 days;Main Objective: The primary objective of this study is to assess the analgesic efficacy of | — |
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
Outcome results
None listed