low back pain MedDRA version: 18.0 Level: LLT Classification code 10024891 Term: Low back pain System Organ Class: 100000004859
Conditions
Interventions
Trade Name: Voltaren®
Product Name: Voltaren®
Pharmaceutical Form: Solution for injection
Trade Name: Muscoril®
Product Name: Muscoril®
Pharmaceutical Form: Solution for injection
Product Name: dicl
Sponsors
Epifarma S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male and female patients aged 18-65 years; • Patients with acute LBP, defined as pain initiating from the area below the tips of the scapulae and above the buttocks, with onset no more than 7 days prior to the screening visit; • Back pain of moderate to severe intensity, defined as = 50 mm at VAS; • If female and of child-bearing potential, the patient must be non-nursing and should not become pregnant throughout the whole study duration; all females of child-bearing potential must have a negative urine pregnancy test prior the first administration; • Satisfactory general health status as determined by the investigator based on medical history and physical examination; • Patients must understand and provide written informed consent before they can participate in the study. They must understand the study procedures of the trial, and be willing to complete the required assessments. 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 240 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 240
Exclusion criteria
Exclusion criteria: • Patients unwilling to give an informed consent approval; • Patients with a history of cervical, thoracic, or lumbosacral pain for = 50% of the time in the year prior to screening; • Patients with presence of lumbosciatalgia; • 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; • Patients with acute LBP caused by a serious or malignant condition; • Patients with acute LBP of traumatic origin; • Patients on treatment with anticoagulant agents; • Patients who underwent spinal surgery in the year prior to screening or had a history of more than one spinal surgery; • Patients who had a history of severe lumbar spinal stenosis, fibromyalgia, or ankylosing spondylitis; • Patients with a medical history of seizures; • Pregnancy or lactation period; • Women with childbearing potential who are not using adequate methods to avoid pregnancy; • Women with polymenorrhea; • History of alcohol or drug abuse; • History of allergy or hypersensitivity or intolerance to diclofenac or thiocolchicoside, and/or to active or inactive excipients of the used investigational study products (IMPs) formulations; • Known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), and in particular to paracetamol; • Use of non-steroid anti-inflammatory drugs (e.g. acetyl salicylic acid) and analgesics (with the exception of paracetamol) in the week before 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; • 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 study. • History of active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration or bleeding within 30 days preceding screening; • History of uncontrolled chronic or acute concomitant disease which, in the Investigator’s opinion, would contraindicate study participation or confound interpretation of the results; • Participation in any other clinical study within 30 days prior to the screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to compare the efficacy of Test and Active Control in improving pain symptoms in patients with acute moderate-severe low back pain (LBP) after 96 ± 2 hours of treatment. Efficacy will be determined by a 100-mm Visual Analogic Scale (VAS) assessment of pain. The VAS is a validated instrument for assessing degree of pain. It consists of a horizontal line, 100 mm in length, where patients put a vertical mark on the line indicating their current perception of pain.;Secondary Objective: The secondary objectives of the study are to compare the efficacy of Test and Active control in: • Pain symptoms (VAS for pain) at all other time points over a treatment period of 5 days; • Spine stiffness (VAS for stiffness) at any time-point; • Time to resolution of pain; • Time to resolution of stiffness; • Consumption of rescue medication (paracetamol); • Tolerability and safety of the IMPs, assessed through summaries of adverse events, the frequency of discontinuation of treatment due to adverse events, laboratory evaluations, ECGs, and vital signs (sitting heart rate, sitting systolic/diastolic blood pressure, respiratory rate, body temperature). ;Primary end point(s): The primary efficacy variable of the study will be the change from baseline in VAS score at rest 96 ± 2 hours after treatment start. This will be the VAS value measured at the investigational study site at Visit 5 (Day 5), one hour after receiving the last IMP administration.;Timepoint(s) of evaluation of this end point: The primary efficacy variable of the study will be the change from baseline at 96 ± 2 hours after treatment start. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy variables • VAS for pain at rest at the other time points over a treatment period of 5 days; • Spine stiffness (VAS for stiffness) at any time-point; • Time to resolution of pain; • Time to resolution of stiffness; • Consumption of rescue medication (paracetamol); Safety variables • Summaries of adverse events and frequency of discontinuation of treatment due to adverse events • Laboratory evaluations; • ECG; • Vital signs (sitting heart rate, systolic/diastolic blood pressure, respiratory rate, body temperature). ;Timepoint(s) of evaluation of this end point: Laboratory tests and ECG will be performed at baseline and at the final visit. All other variables will be evaluated at each study visit. Vital signs will be collected at all study visits, prior the administration of the study drug and one hour after injection. | — |
Countries
Italy
Contacts
Public ContactResponsabile Affari Regolatori
Epifarma S.r.l.
Outcome results
None listed