Low back pain (LBP) is one of the most frequent and disabling health problems. It is estimated that about 80% of adults will experience an episode of acute or chronic LBP at least once during their lifetime The mechanism underlying acute LBP may be disk-, muscle- or posterior articulation-related. The aim of the treatment is always to obtain early and maximum relief of the local and regional pain, as well as to improve mobility and physical function. MedDRA version: 20.0 Level: LLT Classificat
Conditions
Interventions
Trade Name: Non applicabile
Product Name: Diclofenac sodico 75 mg+Tiocolchicoside 4 mg/4 mL soluzione per iniezione
Product Code: [Non applicabile]
Pharmaceutical Form: Solution for injection
INN or P
Sponsors
EPIFARMA S.R.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged = 18 years; 2. Patients with acute LBP at the moment of initiating treatment; LBP is defined as pain initiating from the area below the tips of the scapulae and above the buttocks, with onset no more than 12 weeks prior to the screening visit; 3. Back pain of moderate to severe intensity, defined as = 50 mm at VAS; 4. Patients with stable muscle contracture; a muscle contracture is defined as an increase =65 years) yes F.1.3.1 Number of subjects for this age range 216
Exclusion criteria
Exclusion criteria: 1. Patients with symptoms that might be attributable to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) at inclusion and in the 48 hours preceding the inclusion in the study or contact with subjects positive to SARS-CoV-2 in the 48 hours preceding the inclusion in the study; 2. Patients with a history of cervical, thoracic, or lumbosacral pain for = 50% of the time in the year prior to screening; 3. Patients with presence of lumbosciatalgia; 4. Patients with a history of any LBP episode, except the current acute episode, within 3 months prior to screening that was associated with disability, or required treatment with an opioid analgesic; 5. Patients with acute LBP caused by a serious or malignant condition; 6. Patients with acute LBP of traumatic origin; 7. Patients with acute LBP of infective origin; 8. Patients with acute LBP caused by a rheumatic disease; 9. Patients on treatment with anticoagulant agents; 10. Patients who underwent spinal surgery in the year prior to screening or had a history of more than one spinal surgery; 11. Patients who had a history of severe lumbar spinal stenosis, fibromyalgia, or ankylosing spondylitis; 12. Patients with a medical history of seizures; 13. Pregnancy or lactation period; 14. Women with childbearing potential who are not using adequate methods to avoid pregnancy; 15. Women with polymenorrhea; 16. History of alcohol or drug abuse; 17. History of allergy or hypersensitivity or intolerance to diclofenac or thiocolchicoside, and/or to active or inactive excipients of the used IMPs formulations; 18. Known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs); 19. Use of non-steroid anti-inflammatory drugs (e.g. acetyl salicylic acid) and analgesics (with the exception of diclofenac) in the week before the entry in the study. Chronic intake of small doses of acetylsalicylic acid (= 162 mg/daily) taken for at least 30 days prior to the first dose of study medication for non-analgesic reasons may be continued for the duration of the study; 20. Use of diclofenac in the 12 hours preceding entry in the study; 21. Use of any other treatment or medication that can alter the perception of pain (e.g. heparinoids, opioids, psychotropic agents, anti H1 agents or analgesics like glucocorticosteroids, NSAIDs, etc.) for the same indication or other indications (e.g. rheumatoid arthritis) in the week before the entry in the study; 22. History of active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration or bleeding within 30 days preceding screening; 23. History of uncontrolled chronic or acute concomitant disease which, in the Investigator’s opinion, would contraindicate study participation or confound interpretation of the results; 24. Participation in any other clinical study or investigation within 30 days prior to the screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to demonstrate the superiority of the test fixed combination of diclofenac 75 mg + thiocolchicoside 4 mg given via intramuscular (i.m.) injection over the reference diclofenac 75 mg i.m. and the superiority of both test and reference over placebo i.m., in relieving pain symptoms in adult patients with acute moderate-severe low back pain (LBP) after 48 (± 2) hours from the start of treatment (2 i.m. injections on Day 1 and Day 2 of all investigational medicinal products). Efficacy will be determined by a 100-mm Visual Analogic Scale (VAS) for the assessment of pain;Secondary Objective: The secondary objectives of the study are to compare the efficacy of test, reference end placebo groups in: •Pain symptoms (VAS for pain) at all the other daily time points, up to 7 days from the start of treatment, i.e. 5 days after the 2nd i.m. injection; •Proportion of responder patients after 48 hours (Day 3) and 7 days (Day 7) from the start of treatment; •Muscle contracture (Schober index); •Disability due to LBP, as measured using the Roland Morris disability questionnaire; •Consumption of rescue medication (oral diclofenac 50 mg tablet); •Tolerability and safety of the IMPs, assessed through summaries of adverse events, the frequency of discontinuation of treatment due to adverse events, laboratory evaluations, electrocardiograms (ECGs), and vital signs (sitting heart rate, sitting systolic/diastolic blood pressure, respiratory rate, body temperature). ;Primary end point(s): The primary efficacy endpoint of the study will be the sum of pain intensity difference (SPID) from baseline (Day 1) to Day 3 (4 measurements every 12 hours, 2 in the morning and 2 in the evening) in VAS for pain score at rest. VAS for pain will be measured by patients on Day 1 pre-administration (baseline) and post-baseline measurements will be repeated by patients twice daily (morning and evening). The pain intensity difference (PID) from baseline wil | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary efficacy endpoint Changes from baseline to Day 3 and Day 7 of muscle contracture (Schober index). Other secondary efficacy endpoints • SPID vs. baseline based on morning and evening daily measurements of VAS for pain at all the other daily time points, up to 7 days from the start of treatment, i.e. 5 days after the 2nd i.m. injection; • Proportion of responder patients after 48 hours (Day 3) and 7 days (Day 7) from the start of treatment. A responder is defined as a decrease of VAS for pain = 50% vs. baseline (Day 1, pre-administration). Patients who will intake rescue medication within 48 hours from the start of treatment will be considered as non-responder; • Changes from baseline to Day 3 and Day 7 of disability due to LBP, as measured using the 24-item Roland Morris disability questionnaire; • Use of rescue medication (diclofenac 50 mg tablet): number and percentage of users, number of days with use and number of used tablets, up to Day 3 and up to Day 7; • Time elapsed from date/hour of first study drug administration to first intake of the rescue medication. Safety endpoints • Frequency of adverse events and frequency of discontinuation of treatment due to adverse events • Changes from baseline of safety laboratory parameters; • Electrocardiogram (ECG); • Changes from baseline of vital signs (sitting heart rate, systolic/diastolic blood pressure, respiratory rate, body temperature); • Changes from baseline of findings at clinical examination. | — |
Countries
Greece, Italy
Contacts
Public ContactClinical Operations Department
LB Research
Outcome results
None listed