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

Sprain of Ankle Clinical Trial

— TAASS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01066520
• Other study ID #: TRS-ESP
• Secondary ID: 2008-007939-41
• Status: Completed
• Phase: Phase 3
• First received: February 9, 2010
• Last updated: December 9, 2013
• Start date: August 2009
• Est. completion date: March 2012

Study information

• Verified date: December 2013
• Source: Biologische Heilmittel Heel GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 449
• Est. completion date: March 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Sprain of Ankle

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Spain	MEDYR Medicina Deportiva y Rehabilitación	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Biologische Heilmittel Heel GmbH

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient's Assessment of Ankle Pain (VAS)- Absolute Value Decrease on Day 7	Pain evaluated by a 100 mm visual analogue scale (VAS) where 0 means no pain and 100 means the highest, unbearable pain. The absolute values of VAS have been the basis of analysis.; The highest is the change in negative, the better are the results in absolute values.	From baseline (day 1) visit to day 7	No
Primary	Change of the Foot and Ankle Ability Measurement (FAAM), Activity of Daily Living Subscale (ADL) From Baseline to Day 7	The Foot and Ankle Ability Measure (FAAM) is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments. The Foot and Ankle Ability Measure is a 29-item questionnaire divided into two subscales: the Foot and Ankle Ability Measure, 21-item Activities of Daily Living Subscale and the Foot and Ankle Ability Measure, 8-item Sports Subscale.; Each item is scored on a 5-point Likert scale (4 to 0) from 'no difficulty at all' (score 4), ´slight difficulty´, ´moderate difficulty´, éxtreme difficulty´ to 'unable to do' (score 0). Responses marked as ´not applicable´were not counted.; Item score totals, which range from 0 to 84 for the ADL subscale and 0 to 32 for the Sports subscale, were transformed to percentage scores. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction.	Day 1 to day 7	No
Primary	Patient's Assessment of Ankle Pain (VAS)- Percentage Decrease on Day 7	Pain evaluated by a 100 mm visual analogue scale (VAS) where 0 means no pain and 100 means the highest, unbearable pain. The absolute values of VAS have been the basis of analysis.; The highest is the change in negative, the better are the results in percentages.	From baseline (day 1) visit to day 7	No
Secondary	FAAM ADL Subscale		Day 1 to 4, 14, 42	No
Secondary	FAAM Sports Subscale		Day 1 to 4, 7, 14, 42	No
Secondary	Swelling ('Figure-of-eight')		Day 1 to 4,7,14	No
Secondary	Physician's Assessment of Normal Function/Activity (5-point-scale)		Day 1 to 4, 7, 14, 42	No
Secondary	Time to Normal Function (Training/Sports)		Day 1 to 4, 7, 14, 42	No
Secondary	Global Judgment of Efficacy		Day 14	No

External Links

•   Primary publication paper International Journal of Clinical Practice online