Acute Ankle Sprain
Conditions
Interventions
Trade Name: Traumeel® Gel
Pharmaceutical Form: Gel
Pharmaceutical form of the placebo: Gel
Route of administration of the placebo: Cutaneous use
Trade Name: Diclofenac Heumann Gel
Pharmaceutical Form
Sponsors
Biologische Heilmittel Heel GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Acute unilateral Grade 1 or Grade 2 sprain of the lateral ankle 2. = 18 years of age 3. Legally competent male or female outpatient 4. Injury occurred within previous 24 hours before first treatment expected 5. Signed Informed Consent 6. After 5 minutes of rest, pain on passive movement by investigator measured by Visual Analog Scale (VAS)>50 mm 7. Not pregnant (as proven by negative pregnancy test in case of women of childbearing potential before first study drug administration) or breast-feeding. Females of childbearing potential must agree to maintain highly effective birth control throughout the study (see all details in section 9.6). Such methods include: • oral, intravaginal, transdermal combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, • oral, injectable, implantable hormonal contraception associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner (if received medical assessment of the surgical success), sexual abstinence (only if defined as refraining from heterosexual intercourse during the entire period of trial 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 750 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 58
Exclusion criteria
Exclusion criteria: 1. Similar injury affecting the same joint within the past 6 months 2. Bilateral ankle injury 3. Grade 3 ankle sprain 4. Fracture of the ankle (It should be excluded by using e.g. the Ottawa Ankle Rules. In case of any doubt the exclusion of fracture by x-ray should be considered as per standard of care) 5. Chronic joint disorders such as clinically relevant osteoarthritis or aseptic arthritis 6. Disorders that may lead to joint oedema for other reasons than ankle sprain (such as heart failure, thrombosis, lymphedema and others) 7. Diagnosis requiring bed rest, hospitalization, surgery, or use of any cast during the planned treatment period 8. Debilitating acute or chronic illness 9. Use of systemic and/or topical corticosteroids in the previous 8 weeks, any analgesics (e.g. paracetamol/ acetaminophen) in the previous 24 hours before Screening Visit, or 48 hours in the case of long-acting non-steroidal anti-inflammatory drug (NSAID), cyclooxygenase type 2 (COX-2) specific inhibitors, or tramadol and other opioids. Low dose acetylsalicylic acid (70 – 100 mg per day) for anti-thrombotic therapy is permitted if doses are stable for the month prior to Screening Visit and planned to be stable during the entire study 10. History of sensitivity to any component of the study drugs (including e.g. paracetamol/ acetaminophen intolerance; patients in whom asthma attacks, skin rash or acute rhinitis are triggered by acetylsalicylic acid or non-steroidal anti-inflammatory drugs (NSAIDs) 11. Unwilling or unable to comply with all the requirements of the study protocol 12. Concurrent injury to proximal structures in ipsilateral lower extremity (i.e. concurrent shin, knee, thigh, or hip injury) 13. History of ligament avulsion, fracture or surgery to the affected lower extremity 14. Presence of infections and/or skin diseases in the area of the study treatment site (including psoriasis) 15. Any previous treatments of the injured ankle, whether topical or systematic, are prohibited except RICE (simultaneous combination of all 4 elements Rest, Ice, Compression and Elevation which is restricted to be used until starting treatment with the investigational drug). 16. Participation in any clinical study within the past 4 weeks 17. Any relationship of dependence with the sponsor or with the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to demonstrate the superior efficacy of Traumed® gel versus placebo in patients with acute lateral ankle sprain;Secondary Objective: The secondary objectives are: • to assess non-inferiority of Traumed® gel compared to diclofenac gel • to assess the tolerability and safety of Traumed® gel. ;Primary end point(s): Area under the curve (AUC)* for pain on passive movement in Visual Analog Scale (VAS) from baseline to Day 4 *All AUC calculations will be based on actual time of measurement ;Timepoint(s) of evaluation of this end point: Day 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Variables • AUC for pain at rest in VAS from baseline to Day 4 • AUC for pain on passive movement in VAS from baseline to Day 2, 7 and Final Visit • AUC for pain at rest in VAS from baseline to Day 2, 7 and Final Visit • Change from baseline of pain on passive movement in VAS to Day 4, 7 and Final Visit • Change from baseline of pain at rest in VAS to Day 4, 7 and Final Visit • Change from baseline to Day 2, 4, 7 and Final Visit in the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) subscale • Amount of rescue medication (doses) • Time to 50% improvement of pain at rest measured by VAS Safety Variables • Adverse Events (AEs) • Other observations related to safety (physical examinations and vital signs).;Timepoint(s) of evaluation of this end point: • Day 4 • Day 2, 7 and Final Visit, which is Day 14 • Day 2, 7 and Final Visit, which is Day 14 • Day 4, 7 and Final Visit, which is Day 14 • Day 4, 7 and Final Visit, which is Day 14 • Day 2, 4, 7 and Final Visit, which is Day 14 • whole study duration • tbd Safety Variables • whole study duration • whole study duration | — |
Countries
Germany
Contacts
Public ContactDr. Christine Frank
Biologische Heilmittel Heel GmbH
Outcome results
None listed