Low Back Pain MedDRA version: 21.0 Level: LLT Classification code 10052430 Term: Chronic lumbago System Organ Class: 100000004859
Conditions
Interventions
Trade Name: ITAMI - 140 MG CEROTTO MEDICATO
Product Name: Itami
Product Code: [Itami]
Pharmaceutical Form: Medicated plaster
INN or Proposed INN: DICLOFENAC SODICO
CAS Number: 15307-79-6
Current Sp
Sponsors
FIDIA FARMACEUTICI S.P.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis of mechanical (mild, moderate degenerative process of disc and facet) LBP, for at least 3 months but no more than 6 months, confirmed (thanks to instrumental analysis obtained within 6 months before the Screening visit) by CT or MRI 2. A moderate to severe Chronic LBP, defined as a score greater or = 4 and less or = 8 rated on the NRS-11 3. Age greater than or equal to 40 and less than or equal to 70 years 4. Patient able to maintain a Diary during the study 5. Patient with a Body Mass Index (BMI) =65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. Patients suffering of chronic non-specific LBP 2. Females who are pregnant or breast-feeding 3. Patients who are not able to give informed consent 4. Patients who cannot commit to the entire duration of the study 5. Patients with back pain referred from a mechanical cause (except for mild, moderate degenerative process of disc and facet) non spinal source or back pain associated with another specific spinal cause 6. Patients who have a primary bone disease, cancer, infection 7. Other conditions which may confound the interpretation of the study, such as carpal, rheumatoid arthritis, severe venous diseases, peripheral arterial diseases, transient ischemic attack, stroke, current symptoms of coronary artery disease 8. History of narcotic abuse at any time in the past and/or drug or alcohol abuse in the past year 9. Patients who have had a previous treatment with physical therapy for LBP in the last 4 weeks before the screening visit or are going through a course of physical therapy or chiropractic treatment at the time of planned enrolment 10. Participation in another research study 11. History of epilepsy 12. Patients who have an unstable psychiatric condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate superiority of Tricortin 1000 over placebo in improvement in pain relief as change from baseline to 15 days in patients with chronic low back pain (LBP). ;Secondary Objective: - To compare Tricortin 1000 and diclofenac sodium medicated plaster (Itami®) in improvement in pain relief as change from baseline to 15 days in patients with LBP. - To compare Tricortin 1000 with placebo and diclofenac sodium medicated plaster in functional disability improvement, clinical improvement, patient global assessment (PGA), clinical global impression (CGI), consumption of rescue medication, patient safety as change from baseline to 15 days.;Primary end point(s): Mean change from baseline to Day 15 in NRS-11.;Timepoint(s) of evaluation of this end point: V2-Day 0 (baseline), V3-Day 7, V4-Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): LBP related disability improvement will be measured through the Oswestry Low Back Pain Disability Index (ODI), version 2.1a; Clinical improvement evaluated through the following parameters: - Range of Motion testing - Joint reflex changes (ROT) - Lasegue's test (passive straight leg raise) - Femoral stretch test (Wasserman test) - Dandy's sign - Valleix's points pressure; PGA and CGI of the status of LBP ; Daily rescue medication (paracetamol) required for pain relief ; Safety of daily intramuscular Tricortin 1000 injections and of twice daily diclofenac sodium medicated plaster applications evaluated by physical examination, vital signs and by tracking the number of patient withdrawals and their adverse events at each visit. ;Timepoint(s) of evaluation of this end point: At V2-Day 0 (baseline), V3-Day 7 and V4-Day 15; At V2-Day 0 (baseline), V3-Day 7 and V4-Day 15; At V2-Day 0 (baseline), V3-Day 7 and V4-Day 15; At V2-Day 0 (baseline), V3-Day 7 and V4-Day 15; At V2-Day 0 (baseline), V3-Day 7 and V4-Day 15 | — |
Countries
Italy
Contacts
Public ContactScientific Direction
LB Research S.r.l.
Outcome results
None listed