Chronic neuropathic pain MedDRA version: 6.1 Level: HLGT Classification code 10034606
Conditions
Interventions
Trade Name: TRANSTEC 3 CER.20MG 35MCG/H
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Buprenorphine
CAS Number: 52485-79-7
Concentration unit: µg microgram(s)
Concentration type: equal
C
Sponsors
ISTITUTO NEUROLOGICO CARLO BESTA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -caucasian male or female out-patients - age 18-75 years inclusive - diagnosis of multiple neuropathy or polyneuropathy - unsatisfactory pain control with pre-trial analgesic medication - stable regimen of pre-trial medication for at least 4 weeks - no conditions known to be contraindications to the use of buprenorphine TDS - no conditions that could hinder the evaluation of therapy efficacy and/or tolerability - written informed consent 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: - known hypersensitivity to opioids - opioid dependent patients - patients wha have taken opioids as analgesic - impairmant of respiratory centre and function - patients receiving MAO inhibitors or who have taken MAO inhibitors in the last two weeks - patients with myastenia gravis/delirium tremens/convulsive disorders - incresed intracranial pressure - clinically evident liver function disorders - psychiatric disorders - previous extensive dermal damage in the patch area - pregnant or lactating women - history of alcohol or drug abuse - subjects who have received experimental drugs or have participated in clinical trials within one month prior to screening - employees of the study centre with direct involvement in the study or other studies under the responsibility of the Investigator or study centre
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Valutare se l aggiunta di buprenorfina TDS alla terapia in corso determina un soddisfacente controllo del dolore definito come riduzione 30 dell intensita del dolore valutato con la VAS in pazienti affetti da dolore neuropatico cronico che non ha risposto in modo soddisfacente alla terapia iniziale. La tollerabilita di buprenorfina TDS sara valutata in tutti i pazienti, per l intera durata dello studio.;Secondary Objective: To verify if an adequate pain control can be obtained with buprenorphine TDS monotherapy,to define the optimal dose schedule and to get information on the possible occurrence of withdrawal symptoms and/or pain rebound during the follow up period immediately subsequent to BUP TDS treatment cessation.;Primary end point(s): Pain control reduction 30 of pain severity at VAS | — |
Countries
Italy
Outcome results
None listed