300
Participants
Start Date
March 25, 2019
Primary Completion Date
December 31, 2024
Study Completion Date
January 31, 2025
Tricortin 1000
Tricortin 1000 \[2 mL ampoules containing 12 mg of phospholipids and 1 mg of Vitamin B12 (Cyanocobalamin)\] will be administered intramuscular on the gluteus, once daily (24 hours apart), for 15 days starting from the evening of Day 0 (visit 2) plus Diclofenac sodium medicated plaster placebo will be applied twice daily (12 hours apart) for 15 days starting from the evening of Day 0 (visit 2), i.e. 30 applications.
Itami
Diclofenac sodium 140 mg medicated plaster (Itami®) will be applied twice daily (12 hours apart) for 15 days starting from the evening of Day 0 (visit 2), i.e. 30 applications plus Tricortin 1000 placebo (2 mL ampoules) will be administered intramuscular on the gluteus, once daily (24 hours apart), for 15 days starting from the evening of Day 0 (visit 2).
Placebo
Tricortin 1000 placebo (2 mL ampoules) will be administered intramuscular on the gluteus, once daily (24 hours apart), for 15 days starting from the evening of Day 0 (visit 2) plus Diclofenac sodium medicated plaster placebo will be applied twice daily (12 hours apart) for 15 days starting from the evening of Day 0 (visit 2), i.e. 30 applications.
RECRUITING
ATS Insubria, Porlezza
RECRUITING
ATS Insubria, Erba
RECRUITING
ATS Insubria, Alzate Brianza
RECRUITING
ATS Insubria, Como
RECRUITING
U.O.C. di Riabilitazione Ortopedica, Azienda Ospedaliera Universitaria di Padova, Padua
RECRUITING
U.O.C. Neuroriabilitazione, Dipartimento di Neuroscienze, Azienda Ospedaliera Universitaria Integrata di Verona, Policlinico Borgo Roma, Verona
RECRUITING
SODC-Riabilitazione Azienda ospedaliero-Universitaria Careggi- Ospedale Careggi, Florence
RECRUITING
"UOC Medicina Fisica e Riabilitazione - Unità Spinale Unipolare, Azienda OU Consorziale Policlinico Bari", Bari
RECRUITING
U.O. Medicina Fisica e Riabilitativa Azienda ospedaliera Mater Domini, Catanzaro
RECRUITING
U.O.C. di Riabilitazione AOU Policlinico P. Giaccone, Palermo
RECRUITING
Servizio di Medicina Fisica e Riabilitativa, AOU Policlinico-P.O.G. Rodolico, Catania
RECRUITING
U.O.C. Medicina Fisica Riabilitativa Azienda Policlinoc Umberto I, Università di Roma La Sapienza, Roma
RECRUITING
UOS Medicina Fisica e Riabilitativa Azienda Ospedaliero Universitaria Sant'Andrea-Roma, Roma
Lead Sponsor
Fidia Farmaceutici s.p.a.
INDUSTRY