pain in acute strains, sprains or bruises of the soft tissues following blunt trauma, e.g. sports injuries
Conditions
Interventions
Product Name: Flurbiprofen 40 mg medicated plaster
Product Code: FP-AEU
Pharmaceutical Form: Medicated plaster
INN or Proposed INN: Flurbiprofen
CAS Number: 5104-49-4
Current Sponsor code: FP-AEU
Othe
Sponsors
Lead Chemical Company Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. acute sports-related soft-tissue injury/contusion 2. location of injury such that pain on movement (POM) is elicited on passive manipulation of nearest (or involved) upper or lower limb joint by investigator 3. enrolment within 6 hours of the injury 4. baseline VAS score for (investigator manipulated) POM of injured limb > 50 mm on a 100 mm VAS 5. size of injury, as assessed by investigator, = 25 cm2 and = 120 cm2 6. adult and adolescent male and female patients aged = 16 years 7. having given written informed consent 8. satisfactory health as determined by the Investigator based on medical history and physical examination Are the trial subjects under 18? yes Number of subjects for this age range: 12 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. significant concomitant injury in association with the index acute sports-related soft-tissue injury/contusion; e.g. fracture, nerve injury, ligament disruption, tear of muscle or cartilage, or open wound 2. excessively hairy skin at application site 3. current skin disorder at application site 4. history of excessive sweating inclusive of application site 5. intake of NSAIDs or analgesics within 36 hours, opioids within 7 days, or corticosteroids within 60 days of study start 6. intake of long-acting NSAIDs or application of topical medication since the injury (RICE allowed) 7. participation in a clinical study within 30 days before entry or concomitantly 8. drug or alcohol abuse in the opinion of the investigator 9. pregnant and lactating women 10. women of child-bearing potential who are not using an acceptable method of contraception 11. known hypersensitivity to flurbiprofen, diclofenac sodium or one of the excipients of the plasters. 12. history of NSAID-associated bronchospasm 13. patients with any ongoing condition that may interfere with the absorption, distribution, metabolism, or excretion of flurbiprofen or diclofenac sodium. 14. history of previous significant injury to the same limb within 6 months. 15. patients with a disease affecting the same limb, such as synovitis, rheumatoid arthritis, arthrosis, etc. 16. patients having an ongoing painful condition associated with sports-related injury/contusion. 17. patients suffering from symptoms of an infectious disease including swelling of any joint of the affected upper or lower limbs. 18. patients who had surgery of the affected upper or lower limb within one year of study entry. 19. patients with significant diseases (defined as a disease which, in the opinion of the investigator, may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient’s ability to participate in the study; includes patients with a history of gastrointestinal bleeding, significant cardiovascular, liver or renal disease). 20. patients with a blood coagulation disorder. 21. patients who use any impermissible medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine efficacy and safety of a flurbiprofen 40 mg cutaneous hydrogel medicated plaster (Test) compared to placebo and to a marketed active comparator in patients with acute strains, sprains or bruises (contusions) of the soft tissues following blunt trauma, e.g. sports injuries. To demonstrate that the Test plaster is superior to placebo, is comparable to the active comparator, and that the Test plaster has acceptable local tolerability. ;Secondary Objective: To determine the adhesive power of the plaster. To assess the safety of Flurbiprofen 40 mg cutaneous hydrogel medicated plaster compared with placebo and a marketed active comparator applied once every 12 hours for up to seven days.;Primary end point(s): Pain-on-movement (POM) at injured site in mm measured using a 100 mm Visual Analogue Scale (VAS) at Visit 5 (72 hours after commencement of study treatment);Timepoint(s) of evaluation of this end point: 72 hours after commencement of study treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • POM at injured site in mm measured using a 100 mm VAS at 12, 24, 48 and 96hours after commencement of study treatment • AUC over time during first 24, 48, 72 and 96 hours for POM measured using a VAS; ordinate = POM score in mm, abscissa = time after treatment • PID and SPID at the respective time points for POM and AUC of POM • Pain-at-rest (PAR) at injured site in mm measured using a 100 mm VAS at 12, 24, 48 and 72 hours • Reduction in VAS for POM from baseline: o Time to meaningful reduction (30%) o Time to optimal reduction (50%) • Responder rate 1 (defined as the proportion of patients achieving =50% reduction from baseline in the VAS score for POM at 72 hours) • Responder rate 2 (defined as the proportion of patients able to resume training / normal physical activity by 168 hours) • Time to resume training / normal physical activity • Clinical global assessment of efficacy as judged by investigator and patient at 48, 72 and 168 hours • Overall dose of rescue medication needed (paracetamol) o Time to complete resolution of pain ;Timepoint(s) of evaluation of this end point: 12, 24, 48 and 72 hours | — |
Countries
Germany
Contacts
Public ContactIlias Zontiros
Dr. Regenold GmbH
Outcome results
None listed