Clinical trial NCT01066520: TAASS-Traumeel Ointment and Gel Compared With a Topical NSAID in Athletes With Acute Ankle Sprain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sprain of Ankle
Keywords: ankle sprain
traumeel
diclofenac
antiinflammatory
time to normal function
Lead sponsor: Biologische Heilmittel Heel GmbH
Sponsor class: INDUSTRY
First posted: 2010-02-10
Enrollment: 449
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Patient's Assessment of Ankle Pain (VAS)- Absolute Value Decrease on Day 7
timeFrame: From baseline (day 1) visit to day 7
measure: Change of the Foot and Ankle Ability Measurement (FAAM), Activity of Daily Living Subscale (ADL) From Baseline to Day 7
timeFrame: Day 1 to day 7
measure: Patient's Assessment of Ankle Pain (VAS)- Percentage Decrease on Day 7
timeFrame: From baseline (day 1) visit to day 7
Secondary outcomes:
measure: FAAM ADL Subscale
timeFrame: Day 1 to 4, 14, 42
measure: FAAM Sports Subscale
timeFrame: Day 1 to 4, 7, 14, 42
measure: Swelling ('Figure-of-eight')
timeFrame: Day 1 to 4,7,14
measure: Physician's Assessment of Normal Function/Activity (5-point-scale)
timeFrame: Day 1 to 4, 7, 14, 42
measure: Time to Normal Function (Training/Sports)
timeFrame: Day 1 to 4, 7, 14, 42
measure: Global Judgment of Efficacy
timeFrame: Day 14
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: MEDYR Medicina Deportiva y Rehabilitación
Study officials:
affiliation: National Coordinating Investigator
name: Carlos Gonzalez de Vega, MD
role: STUDY_CHAIR
References:
citation: Gonzalez de Vega C, Speed C, Wolfarth B, Gonzalez J. Traumeel vs. diclofenac for reducing pain and improving ankle mobility after acute ankle sprain: a multicentre, randomised, blinded, controlled and non-inferiority trial. Int J Clin Pract. 2013 Oct;67(10):979-89. doi: 10.1111/ijcp.12219. Epub 2013 Jul 25.