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

Biologische Heilmittel Heel

Status and phase: Completed; Phase 3

Conditions: Sprain of Ankle

Treatments: Drug: Traumeel S gel; Drug: Traumeel S ointment; Drug: Diclofenac gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01066520

TRS-ESP

2008-007939-41 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 449 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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449 participants in 3 patient groups

Traumeel S ointment

Experimental group

Description:

Traumeel S ointment 2 g, 3 times daily topical during 14 days

Treatment:

Drug: Traumeel S ointment

Traumeel S gel

Experimental group

Description:

Traumeel S gel 2 g, 3 times daily topical during 14 days

Treatment:

Drug: Traumeel S gel

Diclofenac gel

Active Comparator group

Description:

Diclofenac gel 2 g, 3 times daily topical during 14 days

Treatment:

Drug: Diclofenac gel