Acute blunt, soft tissue injuries of the muscles or limbs
Conditions
Interventions
Product Name: Loxoprofen sodium 60 mg medicated plaster
Product Code: LX-PU
Pharmaceutical Form: Medicated plaster
INN or Proposed INN: Loxoprofen sodium
CAS Number: 80382-23-6
Current Sponsor code: L
Sponsors
Lead Chemical Company Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Acute sports-related soft-tissue injury/contusion of the upper or lower limb 2. Location of injury such that pain on movement (POM) is elicited on passive manipulation of nearest joint by investigator 3. Enrolment within 6 hours of the injury 4. Baseline VAS score for (investigatormanipulated) POM of injured extremity > 50 mm on a 100 mm VAS 5. Size of injury, as assessed by investigator, = 25 cm2 and = 120 cm2 6. Adult and adolescence male and female patients, age > 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 252 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 240
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 without medically accepted contraception 11. Known hypersensitivity to loxoprofen, ibuprofen or one of the excipients of the plasters 12. Patients with any ongoing condition that may interfere with the absorption, distribution, metabolism, or excretion of loxoprofen or ibuprofen 13. History of previous significant injury to the same extremity within 6 months 14. Patients with a disease affecting the same limb, such as synovitis, rheumatoid arthritis, arthrosis, etc. 15. Patients having an ongoing painful condition associated with sports-related injury/contusion 16. Patients suffering from symptoms of an infectious disease including swelling of any joint of the affected upper or lower limbs 17. Patients who had surgery of the affected upper or lower limb within one year of study entry 18. 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). 19. Patients with a blood coagulation disorder 20. Patients with or with a history of, analgesic-induced asthma 21. Patients who use any impermissible medication (use of systemic or topical NSAIDs, analgesics (other than paracetamol), opioids, corticosteroids (except for topical treatment of bronchial asthma), heparin, or psychotropic agents. Furthermore the application of ice or cooling packs to the injured area after randomization is not permitted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of a Loxoprofen sodium 60 mg medicated plaster applied once a day compared with placebo and a marketed active comparator in patients with acute blunt, soft tissue injuries of the muscles or joints.;Secondary Objective: To assess the safety of Loxoprofen sodium 60 mg medicated plaster compared with placebo and a marketed active comparator applied once daily 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) The analysis of the primary endpoint will be adjusted for baseline values. The baseline adjusted difference between active treatment and placebo at 72 hours should be > 10 mm. Magnitude of reduction in pain will be used to determine ‘responder rate’.;Timepoint(s) of evaluation of this end point: Visual Analogue Scale (VAS) at Visit 5 (72 hours after commencement of study treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. POM at injured site in mm measured using a 100 mm VAS at 24, 48, 96 and 168 hours after commencement of study treatment 2. AUC over time during first 24, 48, 72, 96 and 168 hours for POM measured using a VAS; ordinate = POM score in mm, abscissa = time after treatment 3. Pain-at-rest (PAR) at injured site in mm measured using a 100 mm VAS at 12, 24, 48 and 72 hours 4. Reduction in VAS for POM from baseline: o Time to meaningful reduction (30%) o Time to optimal reduction (50%) o Time to complete resolution of pain 5. Responder rate 1 (defined as the proportion of patients achieving = 50% reduction from baseline in the VAS score for POM at 72 hours 6. Responder rate 2 (defined as the proportion of patients able to resume training / normalphysical activity by 168 hours) 7. Clinical global assessment of efficacy as judged by investigator and patient at 48, 72and 168 hours 8. Overall dose of rescue medication needed (paracetamol) 9. Pain intensity difference (PID) 10. Summary of pain intensity difference (SPID) Other: Adhesive power of plaster (5-point scale) If there is significant use of rescue medication, a sensitivity analysis may be performed to assess impact on primary endpoint and responder rate;Timepoint(s) of evaluation of this end point: 0, 12(+/-2hrs), 24(+/-2hrs) 48(+/-4hrs) 72(+/-4hrs) 96(+/-4hrs) and 168(+/-24hrs)hours after commencement of study treatment | — |
Countries
Germany
Contacts
Public ContactIlias Zontiros
regenold GmbH
Outcome results
None listed