TAASS-Traumeel Ointment and Gel Compared With a Topical NSAID in Athletes With Acute Ankle Sprain
NCT ID: NCT01066520
Last Updated: 2014-01-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
449 participants
INTERVENTIONAL
2009-08-31
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Traumeel S ointment
Traumeel S ointment 2 g, 3 times daily topical during 14 days
Traumeel S ointment
2 g, 3 times daily topical during 14 days
Traumeel S gel
Traumeel S gel 2 g, 3 times daily topical during 14 days
Traumeel S gel
2 g, 3 times daily topical during 14 days
Diclofenac gel
Diclofenac gel 2 g, 3 times daily topical during 14 days
Diclofenac gel
2 g, 3 times daily topical during 14 days
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
40 Years
ALL
No
Sponsors
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Biologische Heilmittel Heel GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Carlos Gonzalez de Vega, MD
Role: STUDY_CHAIR
National Coordinating Investigator
Locations
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MEDYR Medicina Deportiva y Rehabilitación
Madrid, , Spain
Countries
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References
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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.
Related Links
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Primary publication paper International Journal of Clinical Practice online
Other Identifiers
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2008-007939-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TRS-ESP
Identifier Type: -
Identifier Source: org_study_id
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