Patients with acute painful and flogistic (inflammatory) disease due to acute traumatic events (injury/contusion) of joints, muscles, tendons and ligaments
Conditions
Interventions
Product Name: Diclofenac 1% gel
Pharmaceutical Form: Gel
INN or Proposed INN: Diclofenac Diethylamine
CAS Number: 78213-16-8
Other descriptive name: DICLOFENAC DIETHYLAMINE
Concentration unit: % (W/W)
Sponsors
Epifarma s.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged 18-65 years; 2. Patients with acute painful and flogistic (inflammatory) disease due to acute traumatic events (injury/contusion) of joints, muscles, tendons and ligaments); 3. Patient with pain at rest in only one body surface area affected by injury/contusion; 4. Presence of mild to moderate pain at rest, defined as a scored VAS = 20 mm and = 60 mm, in the injured area; 5. Female and of child-bearing potential, (i.e. not in menopausal status from at least one year or permanently sterilized) must have a negative urine pregnancy test prior the first administration; 6. Satisfactory general health status as determined by the investigator based on medical history and physical examination; 7. Patients must understand and provide written informed consent before they 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient unwilling to give an informed consent approval; 2. Patient with presence of pain at rest in more than one body surface area affected by the injury/contusion; 3. Patient with a chronic painful or flogistic disease (from more than three months); 4. Patient with painful or flogistic (inflammatory) disease arising from fractures or severe trauma events; 5. Pregnancy or lactation period throughout the whole study duration; 6. If female and of child-bearing potential, patient not using a highly effective method of birth control. Highly effective birth control methods include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence*; 7. Presence of concurrent skin disorders or open wounds in the area to be treated; 8. History of alcohol or drug abuse; 9. History of allergy or hypersensitivity or intolerance to diclofenac and/or to active or inactive excipients of formulation; 10. Known hypersensitivity to non-steroid anti-inflammatory drugs, and in particular to paracetamol; 11. 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; 12. Any other treatment or medication for the same or other indications 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; 13. Any other concomitant treatment (e.g. cosmetics, ointments at the treated area) or medication that can't be interrupted and interferes with the conduct of the trial; 14. History of active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration or bleeding within 30 days preceding screening; 15. History of uncontrolled chronic or acute concomitant disease which, in the Investigator’s opinion, would contraindicate study participation or confound interpretation of the results; 16. Participation in any other clinical study within 30 days prior to the screening. *Note: According to 4.1 paragraph “Birth control methods which may be considered as highly effective” of the CTFG/Recommendations related to contraception and pregnancy testing in clinical trials (43).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to demonstrate that the Test diclofenac 1% gel produced by Epifarma s.r.l. is non-inferior to the comparator Voltaren® Emulgel® 1% gel, and that both Test and Reference are superior to Placebo gel, in improving pain at rest 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 of maximum 1 week.;Secondary Objective: • Time to resolution of pain at rest; • VAS for pain at rest at the other time points, including the area under the curve (AUC) from baseline up to 96 ± 4 hours; • Proportion of responder patients at 96 ± 4 hours 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 ± 4 hours and at the end of the study; • Global assessment of efficacy by investigator; • Tolerability and safety of the IMPs, assessed through summaries of adverse events, the frequency of discontinuation of treatment due to adverse events, vital signs (sitting heart rate, systolic/diastolic blood pressure, respiratory rate, body temperature), erythema at the IMP application site, and physical examination. ;Primary end point(s): Change from baseline in VAS score for pain at rest 96 ± 4 hours after treatment start;Timepoint(s) of evaluation of this end point: 96 ± 4 hours after treatment start | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy • Time to resolution of pain at rest; • VAS for pain at rest at the other time points, including the AUC from baseline up to 96 ± 4 hours; • Proportion of responder patients at 96 ± 4 hours and at the end of the study. A responder patient is defined as a patient with a decrease of pain at rest = 50% vs. the baseline value; • VAS for pain on movement measured at any time point; • Proportion of patients that will use rescue medication and consumption of rescue medication (paracetamol) during the first 96 ± 4 hours and over the entire study; • Global assessment of efficacy by investigator. Safety • Summaries of adverse events (AEs) and frequency of discontinuation of treatment due to AEs; • Vital signs (sitting heart rate, systolic/diastolic blood pressure, respiratory rate, body temperature); • Erythema at the IMP application site; • Physical examination ;Timepoint(s) of evaluation of this end point: See point E.5.2 | — |
Countries
Germany, Hungary, Italy
Contacts
Public ContactJános Bíró
Bitrial Clinical Research
Outcome results
None listed