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

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biologische Heilmittel Heel GmbH
• Treatments: Diclofenac

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