ocal symptomatic and short-term treatment of pain in acute strains,sprains or bruises of the soft tissues following blunt trauma, e.g.sports injuries
- Conditions
- pain in acute strains, sprains or bruises of the soft tissues following blunt trauma, e.g. sports injuriesTherapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
- Registration Number
- EUCTR2020-005217-41-DE
- Lead Sponsor
- ead Chemical Company Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 312
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method