Acute blunt, soft tissue injuries of the limbs MedDRA version: 20.0 Level: LLT Classification code 10041775 Term: Sprains and strains of ankle and foot System Organ Class: 100000004863 MedDRA version: 20.0 Level: LLT Classification code 10032894 Term: Other specified sites of sprains and strains System Organ Class: 100000004863 MedDRA version: 20.0 Level: LLT Classification code 10041777 Term: Sprains and strains of elbow and forearm System Organ Class: 100000004863 MedDRA version: 20.0 Leve
Conditions
Interventions
Product Name: loxoprofen sodium 60mg tape medicated plaster
Product Code: LX-PU
Pharmaceutical Form: Medicated plaster
INN or Proposed INN: Loxoprofen sodium
CAS Number: 80382-23-6
Current Sponsor cod
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 (investigator manipulated) POM of injured extremity >or equal to 50 mm on a 100 mm VAS 5. size of injury, as assessed by investigator, = 25 cm2 and = 120 cm2 6. adult male and 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 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 132 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 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 concomitantly8. 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. 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 loxoprofen or one of the excipients of the plaster 12. patients with any ongoing condition that may interfere with the absorption, distributionmetabolism, or excretion of loxoprofen 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 (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 tape medicated plaster applied once a day compared with placebo in patients with acute blunt, soft tissue injuries of the limbs. Primary efficacy outcome: 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);Secondary Objective: To assess the safety of Loxoprofen sodium 60 mg tape medicated plaster compared with placebo applied 1 per day for up to 7 days. Secondary efficacy: POM on VAS at V 2, 3, 4, 6 and 7 after start treat. AUC over time during first 24, 48, 72, 96 and 168 h for POM measured using a VAS; ordinate = POM score in mm, abscissa = time after treatment Pain-at-rest at injured site in mm measured using 100 mm VAS at 24, 48 and 72 h Reduction in VAS for POM from baseline: Time to meaningful reduction (30%) -optimal reduction (50%) - complete resolution of pain Responder rate 1 (achieving =50% reduction from baseline in VAS score for POM at 72 h) Responder rate 2 (pat. able to resume training / norm. physical activity by 168 h) Clinical global assessment of efficacy judged invest. and pat. at 48, 72 and 168 h Dose of rescue med. needed (paracetamol) Pain intensity diff. from baseline (PID) for POM meas. by VAS Summary of pain intensity diff. (SPID) for POM meas. by VAS ;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);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): ? POM at injured site in mm measured using a 100 mm VAS at 24, 48, 96 and 168 hours after commencement of study treatment ? 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 ? Pain-at-rest (PAR) at injured site in mm measured using a 100 mm VAS at 24, 48 and 72 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 / normalphysical activity by 168 hours) ?Clinical global assessment of efficacy as judged by investigator and patient at 48, 72and 168 hours ?Overall dose of rescue medication needed (paracetamol) ?Pain intensity difference (PID) ?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 ContactVanessa Hyde
Dr. Regenold GmbH
Outcome results
None listed