PERIPHERAL NEUROPATHIC PAIN DUE TO POST-HERPETIC NEURALGIA OR DIABETIC POLYNEUROPATHY MedDRA version: 9.1 Level: SOC Classification code 10029205 Term: Nervous system disorders
Conditions
Interventions
Trade Name: TRANSTEC*5CER 20MG 35MCG/H
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Buprenorphine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Sponsors
ASSOCIAZIONE ITALIANA PER LO STUDIO DEL DOLORE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - PATIENTS WITH POSTHERPETIC NEUROPATHY OR DIABETIC POLYNEUROPATHY - PATIENTS WITH PERIPHERAL NEURROPATHIC PAIN WITH NRS(NUMERICAL RATING SCALE) > 5 cm - PATIENTS IN TREATMENT WITH PREGABALIN (up to 300 mg/die) WITH INADEQUATE PAIN CONTROL 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
Exclusion criteria: - PATIENTS WITH KNOWN OR SUSPECTED RENAL FAILURE - PATIENTS WITH SEVERE HEPATIC DISORDERS - PATIENTS WITH KNOWN CONTROINDICATIONS OR HYPERSENSITIVITY TO BUPRENORPHINE, PREGABALIN, DICLOFENAC OR ANY OF THE EXCIPIENTS - PATIENTS WITH CARDIAC, COAGULATION OR METABOLIC DESEASES - PATIENTS WITH GASTRIC OR DUODENAL ULCER - PATIENTS WITH ALTERATIONS OF HEMATOPOIESIS - PATIENTS WITH GALACTOSE INTOLERANCE, LAPP LACTASE DEFICIENCY OR GLUCOSE-GALACTOSE MALABSORPTION - PATIENTS IN TREATMENT WITH DIURETIC, ACE INHIBITORS, CORTICOSTEROID, ANGIOTENSIN II-ANTAGONIST AND ANTICOAGULANT - PATIENTS IN TREATMENT WITH MAO-INHIBITORS IN THE LAST 2 WEEKS - EVIDENCE OR HISTORY OF ALCOHOL OR DRUG ABUSE - PSYCHIATRIC ILLNESS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: TO EVALUATE EFFICACY AND TOLERABILITY OF THE ASSOCIATION OF PREGABALIN/TRANSDERMAL BUPRENORPHINE vs THE ASSOCIATION OF PREGABALIN/DICLOFENAC IN PATIENTS WITH PERIPHERAL NEUROPATHIC PAIN DUE TO POSTHERPETIC NEURALGIA OR DIABETIC POLYNEUROPATHY;Secondary Objective: NO;Primary end point(s): TO EVALUATE THE TIME SPENT IN THE TREATMENT GROUP ASSIGNED BY RANDOMIZATION DURING EXPECTED OBSERVATION PERIOD | — |
Countries
Italy
Outcome results
None listed