Impact injury of the limbs Injury, Occupational Diseases, Poisoning Unspecified injury of limb, level unspecified
Conditions
Interventions
Treatment (diclofenac or placebo) is started after enrolment into the trial (at Visit 1, after obtaining informed consent and after physical examination and performance of all trial-specific measureme
Sponsors
Fidia Pharmaceutical [Fidia Farmaceutici S.p.A.] (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or females 2. Age range 18-60 years 3. Outpatients 4. Good general health 5. Written informed consent 6. Fresh impact injury of the limbs presented within 3 hours after injury 7. 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) 8. Pain assessment on movement by patient 40 mm at baseline 9. Visit 1 on a 100 mm Visual Analogue Scale (VAS)
Exclusion criteria
Exclusion criteria: 1. History of blood coagulation disorders 2. History of asthma, chronic obstructive pulmonary disease (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 nonsteroidal antiinflammatory drugs (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 oral corticosteroids within 2 weeks or intravenous corticosteroids 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 |
|---|---|
| Absolute change in pain on movement - assessed while moving the arm lifting a barbell (in case of injury of upper limb) or walking five steps on an even surface (in case of injury of lower limb) Measured at baseline Visit 1 (Day 1) to Visit 3 (Day 3) assessed by patient on Visual Analogue Scale (VAS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain at rest, assessed by patient on VAS on Visit 3, 4 and 5 2. Pain on active movement, assessed by patient on VAS on Visit 4 and 5 3. Algometric pain measurement directly on the skin at the injured site and the contralateral site on Visit 3 and Visit 4 4. Time to onset of efficacy assessed by patient on Visit 2, possibly on Visit 3, 4 and 5, too. If the patient feels that the medication is not yet working at Visit 2, the investigator will ask the patient after the onset of efficacy again at subsequent visits until Visit 5 5. Global assessment of treatment efficacy by patient and by investigator, according to a 5-point Likert scale (none, poor, fair, good, excellent) at Visit 2, 3, 4, 5 6. Consumption of rescue medication at each visit Safety outcomes: 1. Global assessment of local tolerability by patient and by investigator according to a 4-point scale (poor, fair, good, excellent) at Visit 2, 3, 4, 5 2. Changes from baseline to Visit 5 in general physical examination 3. Changes from baseline to Visit 3 and 5 in vital signs 4. Recording of adverse events | — |
Countries
Germany
Outcome results
None listed