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

Purpose

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.

Condition	Intervention	Phase
Sprain of Ankle	Drug: Traumeel S ointment Drug: Traumeel S gel Drug: Diclofenac gel	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac

U.S. FDA Resources

Further study details as provided by Biologische Heilmittel Heel GmbH:

Primary Outcome Measures:

Patient's assessment of ankle pain (VAS)- percentage decrease on day 7 [ Time Frame: From baseline (day 1) visit to day 7 ] [ Designated as safety issue: No ]
Change of the Foot and Ankle Ability Measurement (FAAM), Activity of Daily Living Subscale (ADL) from baseline to day 7 [ Time Frame: Day 1 to day 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change of pain (VAS scale) [ Time Frame: Day 1 to day 4, 14, 42 ] [ Designated as safety issue: Yes ]
ADL FAAM subscale [ Time Frame: Day 1 to 4, 14, 42 ] [ Designated as safety issue: No ]
FAAM sports subscale [ Time Frame: Day 1 to 4, 7, 14, 42 ] [ Designated as safety issue: No ]
Swelling ('figure-of-eight') [ Time Frame: Day 1 to 4, 7, 14, 42 ] [ Designated as safety issue: No ]
Physician's assessment of normal function/activity (5-point-scale) [ Time Frame: Day 1 to 4, 7, 14, 42 ] [ Designated as safety issue: No ]
Swelling ('figure-of-eight') [ Time Frame: Day 1 to 4,7,14,42 ] [ Designated as safety issue: No ]
Time to normal function (training/sports) [ Time Frame: Day 1 to 4, 7, 14, 42 ] [ Designated as safety issue: No ]
Global judgment of efficacy [ Time Frame: Day 14 ] [ Designated as safety issue: No ]

Enrollment:	449
Study Start Date:	August 2009
Study Completion Date:	March 2012
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Traumeel S ointment	Drug: Traumeel S ointment 2 g, 3 times daily topical during 14 days Other Name: Traumeel S ointment, Traumeel S gel, Diclofenac gel
Experimental: Traumeel S gel	Drug: Traumeel S gel 2 g, 3 times daily topical during 14 days Other Name: Traumeel S gel
Active Comparator: Diclofenac gel	Drug: Diclofenac gel 2 g, 3 times daily topical during 14 days Other Name: Diclofenac gel

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.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01066520

Locations

Spain
MEDYR Medicina Deportiva y Rehabilitación
Madrid, Spain

Sponsors and Collaborators

Biologische Heilmittel Heel GmbH

Investigators

Study Chair:

Carlos Gonzalez de Vega, MD

National Coordinating Investigator

More Information

No publications provided

Responsible Party:	Biologische Heilmittel Heel GmbH
ClinicalTrials.gov Identifier:	NCT01066520 History of Changes
Other Study ID Numbers:	TRS-ESP, 2008-007939-41
Study First Received:	February 9, 2010
Last Updated:	October 5, 2012
Health Authority:	Spain: Ministry of Health

Keywords provided by Biologische Heilmittel Heel GmbH:

ankle sprain
traumeel
diclofenac
antiinflammatory
time to normal function

Additional relevant MeSH terms:

Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries
Anti-Inflammatory Agents, Non-Steroidal
Diclofenac
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013