Title
TAASS-Traumeel Ointment and Gel Compared With a Topical NSAID in Athletes With Acute Ankle Sprain
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
Phase
Phase 3Lead Sponsor
Biologische Heilmittel Heel GmbHStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Sprain of AnkleIntervention/Treatment
diclofenac traumeel ...Study Participants
449The 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.
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.
2 g, 3 times daily topical during 14 days
2 g, 3 times daily topical during 14 days
2 g, 3 times daily topical during 14 days
Traumeel S ointment 2 g, 3 times daily topical during 14 days
Traumeel S gel 2 g, 3 times daily topical during 14 days
Diclofenac gel 2 g, 3 times daily topical during 14 days
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
| Event Type | Organ System | Event Term | Traumeel S Ointment | Traumeel S Gel | Diclofenac Gel |
|---|
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.
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.
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.
Outcome Measure Data Not Reported
Outcome Measure Data Not Reported
Outcome Measure Data Not Reported
Outcome Measure Data Not Reported
Outcome Measure Data Not Reported
Outcome Measure Data Not Reported
