TAASS-Traumeel Ointment and Gel Compared With a Topical NSAID in Athletes With Acute Ankle Sprain

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine the efficacy of Traumeel S (both ointment and gel) compared to another antiinflammatory drug called Diclofenac in patients with a sprained ankle.

Detailed Description
-----------------
Study objective is the confirmatory proof of efficacy for Traumeel® S topical treatment, both ointment and gel, as compared to diclofenac topical treatment for patients with ankle sprain. In addition tolerability/safety of both drug preparations is to be compared, so that the benefit-risk relation can be determined.

Official Title
-----------------
A Randomized, Controlled, Multi-center Study on the Effectiveness of Traumeel S (Both Ointment and Gel) in Terms of Pain and Function Compared With a Topical NSAID in Athletes With Acute Ankle Sprain

Conditions
-----------------
Sprain of Ankle

Intervention / Treatment
-----------------
* Drug: Traumeel S ointment
* Drug: Traumeel S gel
* Drug: Diclofenac gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Athletes with an acute unilateral ankle sprain of the lateral ligaments of the ankle joint both male and female Moderate (30-60 mm) to severe (>60 mm) pain according to the patient's assessment of ankle pain visual analogue scale (VAS) on weight bearing, unable to perform normal training / sports activities 18 - 40 years of age injury occurred within 24 hours of the first dose of study medication Willing and able to give written informed consent Available for the duration of the study Exclusion Criteria: Similar injury affecting the same joint within the past 6 months bilateral ankle injury bed rest, hospitalization, surgery use of a non-removable rigid cast Clinically important abnormality for screening laboratory tests Debilitating acute or chronic illness Use of corticosteroids in the previous 8 weeks, any analgesics in the previous 6 hours, or 24 hours in case of long-acting NSAID, COX-2 specific inhibitors, or tramadol History of sensitivity to any component of the study drugs Unwilling or unable to comply with all the requirements of the protocol Participation in other studies within 4 weeks prior to study entry and or during the study participation Current substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of the study result

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Traumeel S ointment<br>Traumeel S ointment 2 g, 3 times daily topical during 14 days | Drug: Traumeel S ointment<br>* 2 g, 3 times daily topical during 14 days<br>* Other names: Traumeel S ointment, Traumeel S gel, Diclofenac gel;|
| Experimental: Traumeel S gel<br>Traumeel S gel 2 g, 3 times daily topical during 14 days | Drug: Traumeel S gel<br>* 2 g, 3 times daily topical during 14 days<br>|
| Active Comparator: Diclofenac gel<br>Diclofenac gel 2 g, 3 times daily topical during 14 days | Drug: Diclofenac gel<br>* 2 g, 3 times daily topical during 14 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's Assessment of Ankle Pain (VAS)- Absolute Value Decrease on Day 7 | Pain evaluated by a 100 mm visual analogue scale (VAS) where 0 means no pain and 100 means the highest, unbearable pain. The absolute values of VAS have been the basis of analysis. The highest is the change in negative, the better are the results in absolute values. | From baseline (day 1) visit to day 7 | 
| Change of the Foot and Ankle Ability Measurement (FAAM), Activity of Daily Living Subscale (ADL) From Baseline to Day 7 | The Foot and Ankle Ability Measure (FAAM) is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments. The Foot and Ankle Ability Measure is a 29-item questionnaire divided into two subscales: the Foot and Ankle Ability Measure, 21-item Activities of Daily Living Subscale and the Foot and Ankle Ability Measure, 8-item Sports Subscale. Each item is scored on a 5-point Likert scale (4 to 0) from 'no difficulty at all' (score 4), ´slight difficulty´, ´moderate difficulty´, éxtreme difficulty´ to 'unable to do' (score 0). Responses marked as ´not applicable´were not counted. Item score totals, which range from 0 to 84 for the ADL subscale and 0 to 32 for the Sports subscale, were transformed to percentage scores. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction. | Day 1 to day 7 | 
| Patient's Assessment of Ankle Pain (VAS)- Percentage Decrease on Day 7 | Pain evaluated by a 100 mm visual analogue scale (VAS) where 0 means no pain and 100 means the highest, unbearable pain. The absolute values of VAS have been the basis of analysis. The highest is the change in negative, the better are the results in percentages. | From baseline (day 1) visit to day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FAAM ADL Subscale |  | Day 1 to 4, 14, 42 | 
| FAAM Sports Subscale |  | Day 1 to 4, 7, 14, 42 | 
| Swelling ('Figure-of-eight') |  | Day 1 to 4,7,14 | 
| Physician's Assessment of Normal Function/Activity (5-point-scale) |  | Day 1 to 4, 7, 14, 42 | 
| Time to Normal Function (Training/Sports) |  | Day 1 to 4, 7, 14, 42 | 
| Global Judgment of Efficacy |  | Day 14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ankle sprain, traumeel, diclofenac, antiinflammatory, time to normal function