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

Primary Purpose

Sprain of Ankle

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Traumeel S ointment
Traumeel S gel
Diclofenac gel
Sponsored by
Biologische Heilmittel Heel GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sprain of Ankle focused on measuring ankle sprain, traumeel, diclofenac, antiinflammatory, time to normal function

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • MEDYR Medicina Deportiva y Rehabilitación

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Traumeel S ointment

Traumeel S gel

Diclofenac gel

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

FAAM ADL Subscale
FAAM Sports Subscale
Swelling ('Figure-of-eight')
Physician's Assessment of Normal Function/Activity (5-point-scale)
Time to Normal Function (Training/Sports)
Global Judgment of Efficacy

Full Information

First Posted
February 9, 2010
Last Updated
December 9, 2013
Sponsor
Biologische Heilmittel Heel GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01066520
Brief Title
TAASS-Traumeel Ointment and Gel Compared With a Topical NSAID in Athletes With Acute Ankle Sprain
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biologische Heilmittel Heel GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sprain of Ankle
Keywords
ankle sprain, traumeel, diclofenac, antiinflammatory, time to normal function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
449 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traumeel S ointment
Arm Type
Experimental
Arm Description
Traumeel S ointment 2 g, 3 times daily topical during 14 days
Arm Title
Traumeel S gel
Arm Type
Experimental
Arm Description
Traumeel S gel 2 g, 3 times daily topical during 14 days
Arm Title
Diclofenac gel
Arm Type
Active Comparator
Arm Description
Diclofenac gel 2 g, 3 times daily topical during 14 days
Intervention Type
Drug
Intervention Name(s)
Traumeel S ointment
Other Intervention Name(s)
Traumeel S ointment, Traumeel S gel, Diclofenac gel
Intervention Description
2 g, 3 times daily topical during 14 days
Intervention Type
Drug
Intervention Name(s)
Traumeel S gel
Intervention Description
2 g, 3 times daily topical during 14 days
Intervention Type
Drug
Intervention Name(s)
Diclofenac gel
Intervention Description
2 g, 3 times daily topical during 14 days
Primary Outcome Measure Information:
Title
Patient's Assessment of Ankle Pain (VAS)- Absolute Value Decrease on Day 7
Description
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.
Time Frame
From baseline (day 1) visit to day 7
Title
Change of the Foot and Ankle Ability Measurement (FAAM), Activity of Daily Living Subscale (ADL) From Baseline to Day 7
Description
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.
Time Frame
Day 1 to day 7
Title
Patient's Assessment of Ankle Pain (VAS)- Percentage Decrease on Day 7
Description
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.
Time Frame
From baseline (day 1) visit to day 7
Secondary Outcome Measure Information:
Title
FAAM ADL Subscale
Time Frame
Day 1 to 4, 14, 42
Title
FAAM Sports Subscale
Time Frame
Day 1 to 4, 7, 14, 42
Title
Swelling ('Figure-of-eight')
Time Frame
Day 1 to 4,7,14
Title
Physician's Assessment of Normal Function/Activity (5-point-scale)
Time Frame
Day 1 to 4, 7, 14, 42
Title
Time to Normal Function (Training/Sports)
Time Frame
Day 1 to 4, 7, 14, 42
Title
Global Judgment of Efficacy
Time Frame
Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Gonzalez de Vega, MD
Organizational Affiliation
National Coordinating Investigator
Official's Role
Study Chair
Facility Information:
Facility Name
MEDYR Medicina Deportiva y Rehabilitación
City
Madrid
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
23889885
Citation
Gonzalez de Vega C, Speed C, Wolfarth B, Gonzalez J. Traumeel vs. diclofenac for reducing pain and improving ankle mobility after acute ankle sprain: a multicentre, randomised, blinded, controlled and non-inferiority trial. Int J Clin Pract. 2013 Oct;67(10):979-89. doi: 10.1111/ijcp.12219. Epub 2013 Jul 25.
Results Reference
derived

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

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