Sprain of AnklePhase 3TAASSNCT01066520
TAASS-Traumeel Ointment and Gel Compared With a Topical NSAID in Athletes With Acute Ankle Sprain
A Phase 3 study testing Traumeel S ointment, Traumeel S gel and Diclofenac gel in people with Sprain of Ankle, run by Biologische Heilmittel Heel GmbH at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Sprain of Ankle
- What is being tested?
- Traumeel S ointment, Traumeel S gel and Diclofenac gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 449 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2009to Mar 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Traumeel S ointment, Traumeel S gel, Diclofenac gel
- Keywords
- ankle sprain, traumeel, diclofenac, antiinflammatory, time to normal function
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traumeel S ointmentDrug
Also called Traumeel S ointment, Traumeel S gel, Diclofenac gel
2 g, 3 times daily topical during 14 days
Traumeel S gelDrug
2 g, 3 times daily topical during 14 days
Diclofenac gelDrug
2 g, 3 times daily topical during 14 days
| Study group | Role | What they receive |
|---|---|---|
| Traumeel S ointment | Experimental | Traumeel S ointment 2 g, 3 times daily topical during 14 days Receives: Drug: Traumeel S ointment |
| Traumeel S gel | Experimental | Traumeel S gel 2 g, 3 times daily topical during 14 days Receives: Drug: Traumeel S gel |
| Diclofenac gel | Active comparator | Diclofenac gel 2 g, 3 times daily topical during 14 days Receives: Drug: Diclofenac gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline (day 1) visit to day 7
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.
Measured: Day 1 to day 7
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.
Measured: From baseline (day 1) visit to day 7
Secondary outcomes (6)
FAAM ADL Subscale
Measured: Day 1 to 4, 14, 42
FAAM Sports Subscale
Measured: Day 1 to 4, 7, 14, 42
Swelling ('Figure-of-eight')
Measured: Day 1 to 4,7,14
Physician's Assessment of Normal Function/Activity (5-point-scale)
Measured: Day 1 to 4, 7, 14, 42
Time to Normal Function (Training/Sports)
Measured: Day 1 to 4, 7, 14, 42
Global Judgment of Efficacy
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2010 (estimated)
- Study startAug 2009
- Primary completionSep 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sprain of AnkleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 449 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biologische Heilmittel Heel GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlos Gonzalez de Vega, MD, Study chair, National Coordinating Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01066520
- Sponsor's protocol ID
- TRS-ESP
- Other IDs
- 2008-007939-41, 2008
- Acronym
- TAASS
- Status last verified
- Dec 2013
- First submitted
- 9 Feb 2010
- Last updated
- 9 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23889885
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01066520
- Acronym / sponsor ID
- TAASS / TRS-ESP
- Conditions
- Sprain of Ankle
- Keywords
- ankle sprain, traumeel, diclofenac, antiinflammatory, time to normal function
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 449 participants (actual)
- Lead sponsor
- Biologische Heilmittel Heel GmbHIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 10 Feb 2010 (estimated)
- Results
- Posted 9 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traumeel S ointment | Experimental | Drug: Traumeel S ointmentTraumeel S ointment 2 g, 3 times daily topical during 14 days |
| Traumeel S gel | Experimental | Drug: Traumeel S gelTraumeel S gel 2 g, 3 times daily topical during 14 days |
| Diclofenac gel | Active comparator | Drug: Diclofenac gelDiclofenac gel 2 g, 3 times daily topical during 14 days |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traumeel S ointmentAlso: Traumeel S ointment, Traumeel S gel, Diclofenac gel2 g, 3 times daily topical during 14 days | Drug | Traumeel S ointment |
| Traumeel S gel2 g, 3 times daily topical during 14 days | Drug | Traumeel S gel |
| Diclofenac gel2 g, 3 times daily topical during 14 days | Drug | Diclofenac gel |
Primary outcome
Patient's Assessment of Ankle Pain (VAS)- Absolute Value Decrease on Day 7
Time frame: From baseline (day 1) visit to 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
Time frame: Day 1 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
Time frame: From baseline (day 1) visit to 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.
6 secondary outcomes
FAAM ADL Subscale
Time frame: Day 1 to 4, 14, 42
FAAM Sports Subscale
Time frame: Day 1 to 4, 7, 14, 42
Swelling ('Figure-of-eight')
Time frame: Day 1 to 4,7,14
Physician's Assessment of Normal Function/Activity (5-point-scale)
Time frame: Day 1 to 4, 7, 14, 42
Time to Normal Function (Training/Sports)
Time frame: Day 1 to 4, 7, 14, 42
Global Judgment of Efficacy
Time frame: Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23889885Gonzalez 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Gonzalez de Vega, MD study chair
National Coordinating Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Traumeel S ointment, Traumeel S gel and Diclofenac gel in people with Sprain of Ankle, run by Biologische Heilmittel Heel GmbH at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's Assessment of Ankle Pain (VAS)- Absolute Value Decrease on Day 7 (time frame: From baseline (day 1) visit to day 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01066520, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2014.