Acute traumatic events (injury/contusion) classified from mild to moderate pain at rest to the joints, muscles, tendons and ligaments MedDRA version: 20.0 Level: SOC Classification code 10022117 Term: Injury, poisoning and procedural complications System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Product Name: Diclofenac 2%
Product Code: Diclofenac 2%
Pharmaceutical Form: Gel
INN or Proposed INN: diclofenac diethylamine
CAS Number: 78213-16-8
Current Sponsor code: diclofenac diethylamine
Ot
Sponsors
Epifarma S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male and female patients aged 18-65 years; • Patients with acute painful and flogistic (inflammatory) disease due to acute traumatic events (injury/contusion) of, joints, muscles, tendons and ligaments. • Patient with pain at rest in only one body surface area affected by the soft tissue injury/contusion; • Presence of mild to moderate pain at rest, defined as a scored VAS = 20 mm and = 60 mm, in the injured area; • Female of child-bearing potential (i.e. not in menopausal status from at least one year) 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 He/She can participate in the study. He/She 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 749 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • Patients unwilling to give an informed consent approval; • Patients with presence of pain at rest in more than one body surface area affected by injury/contusion; • Patients with a chronic painful or flogistic (inflammatory) disease (from not more than three months); • Patients with painful or flogistic (inflammatory) disease arising from fractures or severe trauma events; • Pregnancy or lactation period throughout the whole study duration; • Women with childbearing potential who are not using adequate methods to avoid pregnancy as double barrier or hormonal contraceptive methods; • Presence of concurrent skin disorders or open wounds in the area to be treated; • History of alcohol or drug abuse; • History of allergy or hypersensitivity or intolerance to diclofenac and/or to active or inactive excipients of formulation; • Known hypersensitivity to non-steroid anti-inflammatory drugs, 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; • Any other treatment or medication for the same or other indication that, according to its pharmacological properties and in the opinion of the investigator can alter the perception of pain (e.g. heparinoids, opioids, psychotropic agents, anti H1 agents or analgesics like glucocorticosteroids, NSAIDs, etc.); in the week before the study; • Any other concomitant treatment (e.g. cosmetics, ointments at the treated area) or medication that cannot be interrupted and interferes with the conduct of the trial; • 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 demonstrate that the test (diclofenac2% gel produced by Epifarma) is non-inferior to the reference(Voltaren®Emulgel®2% gel), and that both, test and reference, are superior to placebo gel, in improving pain symptoms in patients with acute painful and flogistic (inflammatory) disease due to acute traumatic events (injury/contusion) of joints, muscles, tendons and ligaments over a treatment period of maximum 1 week. Efficacy will be determined by a 100-mm Visual Analogic Scale (VAS) assessment of pain at rest. The change from baseline in VAS score at rest 96 ± 4 hours after treatment start. be the primary study endpoint. 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 effects, the tolerability and safety of Test and Reference diclofenac2%, and of placebo gel, on: •Time to resolution of pain evaluated at rest; •VAS for pain at rest at the other time points including the AUC from baseline up to 96 ± 4h; •Proportion of responder patients at 96 ± 4h and at the end of the study; •VAS for pain on movement measured at any time point; •Proportion of patients that will use rescue medication and consumption of rescue medication (paracetamol) at 96 ± 4h and at the end of the study; •Global assessment of efficacy by investigator at 96 ± 4h and at the end of the study; •Tolerability and safety of the IMPs, assessed through summaries of adverse events, the frequency of discontinuation of treatment due to adverse eventsand vital signs (sitting heart rate, systolic/diastolic blood pressure, respiratory rate and body temperature), erythema at the IMP application site and physical examination. ;Primary end point(s): The change from baseline in VAS score at rest 96 ± 4 hours after treatment star | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): time to resolution of pain evaluated at rest;Timepoint(s) of evaluation of this end point: From baseline up to 96 ± 4 hours after the treatment start | — |
Countries
Germany, Hungary, Italy, Latvia, Lithuania, Poland
Contacts
Public ContactBiagio Trupa
Epifarma S.r.l.
Outcome results
None listed