E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
pain in acute strains, sprains or bruises of the soft tissues following blunt trauma, e.g. sports injuries |
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E.1.1.1 | Medical condition in easily understood language |
Blunt injuries consists of contusions, strains, sprains and combinations of those |
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E.1.1.2 | Therapeutic area | Diseases [C] - Injuries, poisonings, and occupational diseases [C21] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
72 hours after commencement of study treatment |
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E.5.2 | 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
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Diclofenac-ratiopharm Schmerzpflaster 140 mg wirkstoffhaltiges Pflaster |
Diclofenac-ratiopharm Schmerzpflaster 140 mg wirkstoffhaltiges Pflaster |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS |
Letzter Patient Letzter Besuch |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |