TAASS-Traumeel Ointment and Gel Compared With a Topical NSAID in Athletes With Acute Ankle Sprain
TAASS
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
2 other identifiers
interventional
449
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2009
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 9, 2010
CompletedFirst Posted
Study publicly available on registry
February 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
December 9, 2013
CompletedJanuary 9, 2014
December 1, 2013
2.1 years
February 9, 2010
February 18, 2013
December 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (3)
Traumeel S ointment
EXPERIMENTALTraumeel S ointment 2 g, 3 times daily topical during 14 days
Traumeel S gel
EXPERIMENTALTraumeel S gel 2 g, 3 times daily topical during 14 days
Diclofenac gel
ACTIVE COMPARATORDiclofenac gel 2 g, 3 times daily topical during 14 days
Interventions
2 g, 3 times daily topical during 14 days
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MEDYR Medicina Deportiva y Rehabilitación
Madrid, Spain
Related Publications (1)
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.
PMID: 23889885DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Istvan Zatik
- Organization
- Biologische Heilmittel Heel GmbH
Study Officials
- STUDY CHAIR
Carlos Gonzalez de Vega, MD
National Coordinating Investigator
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2010
First Posted
February 10, 2010
Study Start
August 1, 2009
Primary Completion
September 1, 2011
Study Completion
March 1, 2012
Last Updated
January 9, 2014
Results First Posted
December 9, 2013
Record last verified: 2013-12