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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-007939-41 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traumeel S ointment | Experimental | Traumeel S ointment 2 g, 3 times daily topical during 14 days |
|
| Traumeel S gel | Experimental | Traumeel S gel 2 g, 3 times daily topical during 14 days |
|
| Diclofenac gel | Active Comparator | Diclofenac gel 2 g, 3 times daily topical during 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traumeel S ointment | Drug | 2 g, 3 times daily topical during 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| FAAM ADL Subscale | Day 1 to 4, 14, 42 | |
| FAAM Sports Subscale | Day 1 to 4, 7, 14, 42 | |
| Swelling ('Figure-of-eight') |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Gonzalez de Vega, MD | National Coordinating Investigator | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MEDYR Medicina Deportiva y Rehabilitación | Madrid | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23889885 | Derived | 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. |
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Athletes of both sexes with acute unilateral sprain of the lateral ankle joint; 18 to 40 years of age; injury occurred within 24 hours of the first dose of study medication, with moderate (30-60mm) to severe (>60mm) pain on weight bearing.420 of the enrolled 449 patients have been selected into the ITT population. 447 patients received treatment
Initiation date stage I(299 patients):24.08.2009, completion date stage I: 19.01.2011 Initiation date stage II(150 patients): 04.03.2011, completion date stage II: 12.09.2011 The evaluation criteria have not been changed in the different stages. The interim analysis after Stage I re-confirmed the originally calculated sample size.
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| ID | Title | Description |
|---|---|---|
| FG000 | Traumeel S Ointment | Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing |
| FG001 | Traumeel S Gel | Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing |
| FG002 | Diclofenac Gel | NSAID gel (Diclofenac 1%; standard brand), 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analyzed ITT population
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| ID | Title | Description |
|---|---|---|
| BG000 | Traumeel S Ointment | Traumeel S Ointment 2g, 3 times daily topical during 14 days |
| BG001 | Traumeel S Gel | Traumeel S Gel 2g, 3 times daily topical during 14 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Changes from baseline at day7: absolute values and in percentage. Primary analyses were based on the Intent-To-Treat sample. Only patients with intial VAS<30 mm were excluded from the analysis set. Missing data were handled by the 'Last Observation Carried Forward' method. | Posted | Median | Inter-Quartile Range | Absolute value units on a scale VAS | From baseline (day 1) visit to day 7 |
|
Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Traumeel S Ointment | Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Istvan Zatik | Biologische Heilmittel Heel GmbH | +4972215013192 | istvan.zatik@heel.com |
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| ID | Term |
|---|---|
| D016512 | Ankle Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| Traumeel S gel | Drug | 2 g, 3 times daily topical during 14 days |
|
| Diclofenac gel | Drug | 2 g, 3 times daily topical during 14 days |
|
| Day 1 to 4,7,14 |
| Physician's Assessment of Normal Function/Activity (5-point-scale) | Day 1 to 4, 7, 14, 42 |
| Time to Normal Function (Training/Sports) | Day 1 to 4, 7, 14, 42 |
| Global Judgment of Efficacy | Day 14 |
| BG002 | Diclofenac Gel | Diclofenac Gel 2g, 3 times daily topical during 14 days |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Traumeel S Gel | Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing |
| OG002 | Diclofenac Gel | NSAID gel (Diclofenac 1%; standard brand), 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing |
|
|
| 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. | Changes to Baseline: absolute values. Primary analyses were based on the Intent-To-Treat sample. Only patients with intial VAS<30 mm were excluded from the analysis set. Missing data were handled by the 'Last Observation Carried Forward' method. | Posted | Median | Inter-Quartile Range | Scores on a scale | Day 1 to day 7 |
|
|
|
| Secondary | FAAM ADL Subscale | Not Posted | Day 1 to 4, 14, 42 |
| Secondary | FAAM Sports Subscale | Not Posted | Day 1 to 4, 7, 14, 42 |
| Secondary | Swelling ('Figure-of-eight') | Not Posted | Day 1 to 4,7,14 |
| Secondary | Physician's Assessment of Normal Function/Activity (5-point-scale) | Not Posted | Day 1 to 4, 7, 14, 42 |
| Secondary | Time to Normal Function (Training/Sports) | Not Posted | Day 1 to 4, 7, 14, 42 |
| Secondary | Global Judgment of Efficacy | Not Posted | Day 14 |
| 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. | Posted | Median | Inter-Quartile Range | Percentage change in scale VAS | From baseline (day 1) visit to day 7 |
|
|
|
| 0 |
| 152 |
| 11 |
| 152 |
| EG001 | Traumeel S Gel | Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing | 0 | 148 | 15 | 148 |
| EG002 | Diclofenac Gel | NSAID gel (Diclofenac 1%; standard brand), 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing | 0 | 147 | 8 | 147 |
| Swelling | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Nasopharingitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Joint injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Joint sprain | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypoasthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Oropharingeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
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