NCT01066520

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 449 (actual)
• Sponsor: Biologische Heilmittel Heel GmbH · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sprain of Ankle

Interventions

Type	Name	Description
DRUG	Traumeel S ointment	2 g, 3 times daily topical during 14 days
DRUG	Traumeel S gel	2 g, 3 times daily topical during 14 days
DRUG	Diclofenac gel	2 g, 3 times daily topical during 14 days

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-09-01
• Completion: 2012-03-01
• First posted: 2010-02-10
• Last updated: 2014-01-09
• Results posted: 2013-12-09

Locations

1 site across 1 country: Spain