Acute pain in mild/moderate ankle sprains MedDRA version: 21.1 Level: PT Classification code 10024453 Term: Ligament sprain System Organ Class: 10022117 - Injury, poisoning and procedural complications MedDRA version: 23.1 Level: SOC Classification code 10022117 Term: Injury, poisoning and procedural complications System Organ Class: 10022117 - Injury, poisoning and procedural complications MedDRA version: 20.0 Level: HLT Classification code 10028288 Term: Muscle, tendon and ligament injuries
Conditions
Sponsors
IBSA Institut Biochimique S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male or female outpatients, aged = 18 and = 65 years; 2. Acute Grade I or II ankle sprain involving the lateral ligaments (i.e., inversion mechanism); 3. Ankle sprain occurred = 48 hours before inclusion in the study; 4. Ankle sprain with pain on movement (while performing normal daily activities) with a score of = 5 on the Numeric Rating Scale (NRS); 5. Females of childbearing potential (i.e., not permanently sterilised - post hysterectomy or tubal ligation status – or not postmenopausal) must have a negative urine pregnancy test result at screening/inclusion visit and must use an appropriate method of contraception for at least 30 days before inclusion in the study and for 7 days after the last dose, according to the definition in ICH M3 (R2) Guidelines; 6. Subject having provided their written informed consent to study participation. 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 454 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. Positive or missing pregnancy test at screening/inclusion visit, or breast-feeding women; 2. Sprain occurred > 48 h prior to study enrolment; 3. Severe (Grade III) ankle sprain or ankle sprain requiring an orthopaedic, surgical or physiotherapeutic treatment; 4. Baseline (pre-treatment) self-evaluation of pain on movement by NRS of = 5; 5. Non-intact or damaged skin within the area to be treated, e.g., eczema, psoriasis, exudative dermatitis, infected lesion, burn or wound; 6. Three or more prior injuries to the affected ankle in the past; 7. Relapsing sprains already treated during the 6 months preceding the study inclusion; 8. Any other significant injury (such as fracture or torn ligament), or surgery (except for skin and nails) of the affected ankle or foot during the past 6 months; 9. Prior use of any topical medication to the affected area within 48 hours to inclusion in the study; 10. Prior use of analgesic, NSAIDs, or COX-inhibitors, by any route, within 48 hours or 5 half-lives before inclusion in the study, whichever is longer (oral paracetamol permitted until 3 hours before inclusion/baseline pain assessment). Use of stable daily doses of aspirin taken for non-analgesic reasons for at least 30 days prior to inclusion may be continued for the duration of the study; 11. Prior use of narcotic analgesics within 7 days before study entry, prior use of systemic corticosteroids by any route of administration within 60 days preceding inclusion in the study; 12. Ankle sprain treated prior to inclusion in the study with physiotherapy, ultrasound, acupuncture or physical therapy (RICE permitted until 3 hours before inclusion/baseline pain assessment); 13. Use within 30 days prior to inclusion of immunomodulators or immunosuppressive therapies or interferon; 14. Known allergy or hypersensitivity to diclofenac, aspirin or other NSAIDs, including paracetamol, or any excipient in the tested products; 15. Medical history of: - asthma, urticaria, angioedema, or bronchospasm; - ulcer disease, gastrointestinal bleeding, inflammatory bowel disease; - coagulation defects, hemorrhagic diathesis; - severe hepatic or renal impairment; - severe cardiac/cardiovascular conditions, including NYHA Class III and IV congestive heart failure (CHF), and unstable, uncontrolled hypertension; - any chronic pain disorder; - severe systemic disease (e.g., cancer, severe acute infection); 16. Major psychiatric disorders that, according to the Investigator, could compromise the subject’s participation in the study; 17. History of alcohol or drug abuse (within previous 12 months); 18. Subjects refusing to give a written informed consent; 19. Concomitant participation in other clinical trials or participation in the evaluation of any investigational product during 3 months before this study or previous participation in the same study; 20. Participation in the study is also not permitted to employees of the Investigator or study site with direct involvement in the trial or in other trials under the direction of that Investigator, as well as family members of the employees or of the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether DHEP 2.6% medicated plaster applied once-a-day for 7 days is superior in relieving pain due to recent mild/moderate ankle sprain, as compared to a placebo (vehicle) plaster. To assess if DHEP 2.6% medicated plaster applied once-a-day for 7 days is non-inferior in relieving pain due to recent mild/moderate ankle sprain, as compared to the reference marketed product Flector®, applied twice-a-day (two applications of 12 h each) during the 7-day treatment period.;Secondary Objective: Evaluation the tested products in terms of: effect on ankle oedema effect on ankle joint function effect on rescue medication intake Investigator's judgment of global efficacy adhesion (including use of reinforcement with an elastic net sleeve, as needed) subject's compliance to treatment;Primary end point(s): The two co-primary efficacy endpoints of the study (that will be analysed according to a hierarchical approach) are: • Change in baseline of (mean) POM reduction after 3 days of DHEP 2.6% medicated plaster is greater than placebo (vehicle) plaster. • Change in baseline of (mean) POM reduction after 3 days of DHEP 2.6% medicated plaster is no worse than the comparator Flector®.;Timepoint(s) of evaluation of this end point: From Baseline line Day 0 to Day 3 Included | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoints of the study will be the comparisons between treatment groups of the following parameters: POM at in-clinic visits, POM day-by-day, evaluation of peri-malleolar oedema, affected ankle joint function, rescue medication consumption, onset of pain relief, rate of responders (proportion of subjects achieving a 50% POM reduction), overall treatment efficacy.;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Czech Republic, Germany, Poland
Contacts
Public ContactR&D Scientific Affairs Specialist
IBSA Institut Biochimique S.A.
Outcome results
None listed