Effectiveness of Tricortin 1000 in Patients Affected by Chronic Low Back Pain

PHASE4RecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

March 25, 2019

Primary Completion Date

December 31, 2024

Study Completion Date

January 31, 2025

Conditions
Low Back Pain, Mechanical
Interventions
DRUG

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.

DRUG

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).

DRUG

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.

Trial Locations (13)

22018

RECRUITING

ATS Insubria, Porlezza

22036

RECRUITING

ATS Insubria, Erba

22040

RECRUITING

ATS Insubria, Alzate Brianza

22100

RECRUITING

ATS Insubria, Como

35128

RECRUITING

U.O.C. di Riabilitazione Ortopedica, Azienda Ospedaliera Universitaria di Padova, Padua

37134

RECRUITING

U.O.C. Neuroriabilitazione, Dipartimento di Neuroscienze, Azienda Ospedaliera Universitaria Integrata di Verona, Policlinico Borgo Roma, Verona

50139

RECRUITING

SODC-Riabilitazione Azienda ospedaliero-Universitaria Careggi- Ospedale Careggi, Florence

70125

RECRUITING

"UOC Medicina Fisica e Riabilitazione - Unità Spinale Unipolare, Azienda OU Consorziale Policlinico Bari", Bari

88100

RECRUITING

U.O. Medicina Fisica e Riabilitativa Azienda ospedaliera Mater Domini, Catanzaro

90127

RECRUITING

U.O.C. di Riabilitazione AOU Policlinico P. Giaccone, Palermo

95123

RECRUITING

Servizio di Medicina Fisica e Riabilitativa, AOU Policlinico-P.O.G. Rodolico, Catania

00185

RECRUITING

U.O.C. Medicina Fisica Riabilitativa Azienda Policlinoc Umberto I, Università di Roma La Sapienza, Roma

00189

RECRUITING

UOS Medicina Fisica e Riabilitativa Azienda Ospedaliero Universitaria Sant'Andrea-Roma, Roma

Sponsors
All Listed Sponsors
lead

Fidia Farmaceutici s.p.a.

INDUSTRY