ocal symptomatic and short-term treatment of pain in acute strains, sprains or bruises of the muscles or joints following blunt trauma, e.g. sports injuries

Phase 1

• Conditions: Acute blunt, soft tissue injuries of the muscles or limbs; Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

• Registration Number: EUCTR2020-003543-29-DE
• Lead Sponsor: ead Chemical Company Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-22
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 264

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>mm Visual Analogue Scale (VAS) at Visit 5 (72 hours after<br>commencement of study treatment)<br><br>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<br>study treatment)