Clinical study to evaluate the efficacy and safety of an etofenamate 5% cutaneous patch vs. placebo in the treatment of acute uncomplicated unilateral ankle sprai
- Conditions
- Ankle sprain, Grade I or IITherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2014-001720-30-DE
- Lead Sponsor
- Drossapharm AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
1. Acute uncomplicated unilateral ankle sprain, Grade I or II
2. Enrolment within 12 hours of the injury
3. Baseline VAS score for (investigator manipulated) pain on movement (POM) of injured ankle = 50 mm on a 100 mm VAS
4. Adult male or female patients
5. Age 18 to 60 years
6. Having given written informed consent
7. 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 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Key exclusion criteria:
Patients eligible for inclusion in this clinical trial must not fulfill any of the following criteria:
1. Serious injury in the area of the foot or ankle, including fracture, nerve injury, ligament disruption, tear of muscle or cartilage, or open wound
2. Excessively hairy skin at application site
3. Chronic 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 clinical trial start
6. Intake of long-acting NSAIDs or application of topical medication since the injury (RICE allowed)
7. Participation in a clinical clinical trial 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 without medically accepted contraception
11. Known hypersensitivity to etofenamate or one of the excipients of the patch
12. History of previous grade I ankle sprain (same ankle) within 6 months, or previous grade II sprain, or other significant injury to the same ankle or foot within 6 months.
13. Patients with history of previous grade III ankle sprain (same ankle).
14. Patients with a disease affecting the same ankle, such as synovitis, rheumatoid arthritis, arthrosis, etc.
15. Patients suffering from symptoms of an infectious disease including swelling of any joint of the affected lower limb
16. Patients who had surgery of the affected lower limb within one year of clinical trial entry
17. 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 clinical trial or a disease which may influence the results of the clinical trial or the patient’s ability to participate in the clinical trial; includes patients with a history of gastrointestinal bleeding, significant cardiovascular, liver or renal disease).
18. Patients with a blood coagulation disorder
19. 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 Main Objective: To evaluate the efficacy of an EFM 5% patch compared with placebo applied two times a day in subjectpatients with acute ankle sprains, in particular with regard to pain relief. <br>;Secondary Objective: To assess the safety of an EFM 5% patch compared with placebo ;Primary end point(s): The primary efficacy outcome is ankle pain-on-movement (POM) assessed by Visual Analogue Scale (VAS) at Visit 5 (72 hours after initiating treatment).;Timepoint(s) of evaluation of this end point: Visit 5 (72 hours after initiating treatment)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Important secondary efficacy outcomes are POM on VAS <br><br>2. Safety assessments:<br>a. Physical examination<br>b . Skin damage/reaction associated with patch removal <br>c. Vital signs (including blood pressure and pulse rate) <br>d. Adverse events (AEs)<br>;Timepoint(s) of evaluation of this end point: 1. Visit 4 (48 hours after initiating treatment) and Visit 6 (96 hours after initiating treatment).<br><br>2. Safety assessments:<br>a. V 1 and V7<br>b. every visit except V1<br>d. V1 and V7<br>e. every visit<br>