Fresh impact injuries of the limbs (Contusions, strains and sprains)
Conditions
Interventions
Product Name: Diclofenac Sodium 140 mg Medicated Plaster
Product Code: not applicable
Pharmaceutical Form: Medicated plaster
INN or Proposed INN: Diclofenac Sodium
CAS Number: 15307-79-6
Current Spons
Sponsors
Fidia Farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or females, age range 18-60 years, outpatients. 2. Good general health. 3. Written informed consent. 4. Fresh impact injury of the limbs presented within 3 hours after injury. 5. The size of the visible traumatisation must be at least 25 cm2 and maximal 150 cm2 (in case of a muscle strain the area is assessed through palpation). 6. Pain assessment on movement by patient greater or equal 40 mm at baseline 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of blood coagulation disorders. 2. History of asthma, COPD, hay fever and swelling of nasal mucosa. 3. Pregnancy or lactation period. 4. Women with childbearing potential without effective contraceptive methods. 5. Known allergy or hypersensitivity to: Diclofenac, paracetamol, acetylsalicylic acid, salicylic acid, other NSAIDs or cyclooxygenase 2-specific inhibitor (COXIB) or known intolerance (cutaneous or systemic) to any of the ingredients of the plaster, such as butylated methacrylate copolymer, copolymer acrylate vinyl acetate, PEG 12 stearate, sorbitan oleate. 6. Current skin disorders/open wounds in the area to be treated. 7. Gastric and intestinal ulcer. 8. Gastrointestinal, cerebrovascular or other active bleedings. 9. Evidence of liver, kidney or haematopoetic disorders. 10. Patients affected by rheumatoid arthritis or gout. 11. Known malignant diseases in the last 5 years. 12. Pre-treatment of injury. Previous cooling (ice, cooling spray) is authorised prior to screening . It is also allowed to cool the injury during the screening period until randomisation with a moist cloth and water at room temperature (no ice, no cooling spay). 13. Any patient, in the investigators opinion not considered suitable for enrolment. 14. Anticipated poor compliance by the patient. 15. Use of non-steroidal anti-inflammatory drugs, analgesics (e.g. acetyl salicylic acid, with the exception of paracetamol) or psychotropic agents within 3 days before trial participation or corticosteroids oral within 2 weeks or intravenous within 4 weeks before trial participation. 16. Use of glucosamine, chondroitine sulphate, diacerine, hyaluronic acids and bisposphonates in the last 4 weeks. 17. Participation in another clinical trial and/or treatment with an experimental drug within 4 weeks before participation in the trial. 18. Previous participation in this clinical trial. 19. Any relevant surgical treatment during the previous 2 months or planned during the trial. 20. Patient with a history of serious psychiatric disorders. 21. Abuse of alcohol, medicaments or illicit drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to show superior efficacy of Diclofenac Sodium 140 mg medicated plaster over Placebo plaster as assessed by absolute change of pain on movement from baseline Visit 1 (Day 1) to Visit 3 (Day 3) in the indication fresh impact injuries of the limbs. ;Secondary Objective: The secondary objectives of the clinical trial are the evaluation of the trial drug's efficacy with reagrd to secondary efficacy variables and safety in comparison to Placebo.;Primary end point(s): Absolute change in pain on movement from baseline Visit 1 (Day 1) to Visit 3 (Day 3) (whil moving the arm or walking 5 steps on an even surface) assesed by patient on Visual Analogue Scale (VAS) | — |
Countries
Germany
Outcome results
None listed