Patients with painful and phlogistic (inflammatory response) disease due to acute traumatic events (injury/contusion) of the limbs
Conditions
Interventions
Product Name: Diclofenac sodium 140 mg medicated plaster
Product Code: EQI7
Pharmaceutical Form: Medicated plaster
INN or Proposed INN: DICLOFENAC SODIU
Sponsors
Fidia Farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria will be enrolled in the study: 1. Male or female, age range 18-65 years (included); 2. Patient with painful and phlogistic (inflammatory response) disease due to acute traumatic events (injury/contusion) of the limbs; 3. Patient with pain at rest in only one limb surface area affected by injury/contusion; 4. Written informed consent to participate in the study obtained according to GCP; 5. Patients able to comprehend the full nature and the purpose of the study, including possible risks and side effects, and able to cooperate with the Investigator and to comply with the requirements of the entire study (including ability to attend all the planned study visits according to the time limits), based on Investigator’s judgement; 6. Good general health as determined by the Investigator based on medical history and physical examination; 7. Female 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 IMP administration; 8. Presence of pain at rest in the injured area, defined by patient with a VAS =40 mm and =80 mm at Visit 1 on a 100 mm VAS. 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 205 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: Patients who fulfil any of the following criteria will not be enrolled in the study: 1. Patient with a chronic painful or phlogistic disease (from more than three months); 2. Patient with painful or phlogistic disease arising from fractures or severe trauma events; 3. Pregnancy or lactation period throughout the whole study duration; 4. If female and of child-bearing potential, patient not using a highly effective method of birth control. Highly effective birth control methods include: combined hormonal contraception (containing estrogen and progestogen) 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*; 5. Presence of concurrent skin disorders or open wounds in the area to be treated; 6. History of alcohol or drug abuse; 7. History of allergy or hypersensitivity or intolerance to diclofenac and/or to active or inactive excipients of formulation; 8. Known hypersensitivity to non-steroidal anti-inflammatory drugs and to paracetamol; 9. Use of non-steroid anti-inflammatory drugs and analgesics in the week before Visit 1 (with the exception of paracetamol, which should not be taken in the previous 8 hours), oral corticosteroids within 2 weeks or intravenous corticosteroids within 4 weeks before Visit 1. Chronic intake of small doses of acetylsalicylic acid (= 162 mg/day) taken for at least 30 days prior to the first dose of study medication for non-analgesic reasons may be continued (with no change on dosage) for the duration of the study; 10. 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 or other anticoagulant agents, opioids, psychotropic agents, anti H1 agents or analgesics like glucocorticosteroids, etc.) in the week before Visit 1; 11. 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; 12. History of active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration or bleeding within 30 days before Visit 1; 13. History of uncontrolled chronic or acute concomitant disease which, in the Investigator’s opinion, would contraindicate study participation or confound interpretation of the results; 14. Known malignant diseases in the last 5 years; 15. Pre-treatment of the traumatic event (injury/contusion) target of this study. Previous cooling (with ice, cooling spray) is authorized prior to Visit 1 (but not in the three hours preceding Visit 1); 16. Anticipated poor compliance by the patient; 17. Previous participation in this clinical trial; 18. Any relevant surgical treatment during the previous 2 months or planned during the trial; 19. Patient with a history of serious psychiatric disorders; 20. Participation i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to show non-inferior efficacy of Test Diclofenac Sodium 140 mg medicated plaster (once a day) over a Reference Diclofenac epolamine (DIEP) 180 mg medicated plaster, Flector® (once a day), and that both Test and Reference are superior to Placebo plaster (once a day) in improving pain at rest at 72 ± 2 hours (Day 4) after treatment start in patients with painful and phlogistic (inflammatory response) disease due to acute traumatic events (injury/contusion) of the limbs. A 100-mm Visual Analogue Scale (VAS) will be used for the assessment of pain at rest.; Secondary Objective: The secondary objectives of the clinical trial are to evaluate: The efficacy of the Test product in comparison to Reference and Placebo with regard to pain relief (pain at rest and pain on movement), consumption of rescue medication and global assessment of efficacy by patient; The adhesion of the Test product in the site of application in comparison to Reference and Placebo; The general safety and local tolerability of the Test product in comparison to Reference and Placebo. ;Primary end point(s): Change from baseline in VAS score for pain at rest at 72 ± 2 hours (Day 4) after treatment start.;Timepoint(s) of evaluation of this end point: 72 hours ± 2 hours after treatment start | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: It depends on the endpoint considered. See previous section.; Secondary end point(s): Efficacy parameters • Area under the curve (AUC) for pain at rest at Day 4 and Day 8 (SPID0-4d and SPID0-8d); • Change from baseline of VAS for pain at rest at the other study time-points (including patients’ home measurements); • Time to resolution of pain at rest; • Change from baseline in VAS score for pain on movement at 72 ± 2 hours (Day 4) and at 192 ± 2 hours (Day 8) after treatment start; • Proportion of responder patients (defined as a decrease = 50% of baseline VAS for pain at rest and on movement) at 72 ± 2 hours (Day 4) after treatment start; • Proportion of patients that will use rescue medication (paracetamol) and consumption of rescue medication during the entire study period; • Global assessment of efficacy by patient, performed at 72 ± 2 hours (Day 4) and at 192 ± 2 hours (Day 8) after treatment start; • Assessment of the adhesion of the medicated plaster IMP in the site of application, performed daily by patients and at 72 ± 2 hours (Day 4) and at 192 ± 2 hours (Day 8) after treatment by the “open” member of the staff. Safety parameters • Summaries of adverse events (AEs) and frequency of discontinuation of treatment due to AEs; • Local tolerability (erythema, itching, burning and local pain) at the IMP application site; • Investigator’s and patient’s opinion on local tolerability; • Change from baseline in vital signs (blood pressure and heart rate); • Abnormalities in the physical examination. | — |
Countries
Germany, Hungary
Contacts
Public ContactFlavia Baruzzi
LB Research s.r.l.
Outcome results
None listed