Acute strains, sprains or bruises of the extremities following blunt trauma MedDRA version: 20.0 Level: LLT Classification code 10002549 Term: Ankle sprain System Organ Class: 100000004863 MedDRA version: 20.0 Level: LLT Classification code 10002550 Term: Ankle sprains and strains System Organ Class: 100000004863 MedDRA version: 20.0 Level: LLT Classification code 10028338 Term: Muscle sprains System Organ Class: 100000004863 MedDRA version: 20.0 Level: LLT Classification code 10028361 Term:
Conditions
Interventions
Product Name: Esflurbiprofen hydrogel patch
Product Code: EFHP 165 mg
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: esflurbiprofen
CAS Number: 5104-49-4
Current Sponsor code: Esflurbip
Sponsors
Teikoku Seiyaku Co Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. acute sports-related soft-tissue injury/contusion (strains, sprains, bruises) of the upper or lower limb 2. location of injury such that pain-on-movement (POM) is elicited on by the exercises described in Section 7.5 3. enrollment within 6 hours of the injury 4. baseline VAS score for 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 male or female patients 7. age 18 to 60 years 8. having given written informed consent 9. satisfactory health as determined by the Investigator based on medical history and physical examination. 10. Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception defined as: • Surgical sterilization • Hormonal contraception • IUD • Double barrier method Periodic abstinence is NOT an acceptable method of contraception. An acceptable method of contraception must be maintained throughout the study. A woman who is post-menopausal must have a negative urine pregnancy test at screening but will not need to comply with an acceptable method of contraception. Women are considered post-menopausal and not of child bearing potential if they had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. 11. known hypersensitivity to Esflurbiprofen or one of the excipients of the patch 12. patients with any ongoing condition that may interfere with the absorption, distribution, metabolism, or excretion of Esflurbiprofen 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 who use any impermissible medication Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
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, cutting the hair in the injured site prior to patch application will qualify for inclusion 3. current skin disorder or shaving hair at application site 4. history of excessive sweating/hyperhidrosis inclusive of application site 5. intake of NSAIDs or analgesics within 36 hours, opioids within 7 days, or corticosteroids within 60 days of inclusion in the study 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 inclusion in the study or concomitantly 8. drug or alcohol abuse in the opinion of the investigator 9. Pregnant and lactating women 10. Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception defined as: • Surgical sterilization • Hormonal contraception • IUD • Double barrier method • Total abstinence throughout the study at the discretion of the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of a Esflurbiprofen 165 mg Hydrogel Patch applied once a day compared with placebo in patients with acute blunt, soft tissue injuries of the limbs. • The primary efficacy outcome is pain-on-movement (POM) change from baseline assessed by Visual Analogue Scale (VAS) to Visit 5 (72 hours after initiating treatment). • Important secondary efficacy outcomes are POM on VAS at Visit 2, 3, 4, 6 and 7 (12, 24, 48, 96 and 168 hours after initiating treatment). ;Secondary Objective: To assess the safety of Esflurbiprofen Hydrogel Patch compared with placebo applied once a day for up to seven days.;Primary end point(s): Change from baseline in pain-on-movement (POM) at injured site in mm measured using a 100 mm Visual Analogue Scale (VAS) to 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, 72, 96 and 168 hours 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 • Pain-at-rest (PAR) at injured site in mm measured using a 100 mm VAS at 12, 24, 48, 72, 96 and 168 hours • 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 • 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) • Clinical global assessment of efficacy as judged by investigator and patient at 48, 72 and 168 hours • Overall dose of rescue medication needed (paracetamol) Other: • Adhesive power of patch (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: 12, 24, 48, 72, 96 and 168 hours after commencement of study treatment | — |
Countries
Germany
Contacts
Public ContactElke Klimmeck
Clinsearch GmbH
Outcome results
None listed