Phase 3
N=420
TAASS-Traumeel Ointment and Gel Compared With a Topical NSAID in Athletes With Acute Ankle Sprain
Sprain of Ankle
Bottom Line
View on ClinicalTrials.gov: NCT01066520 ↗Enrolled (actual)
420
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: Patient's Assessment of Ankle Pain (VAS)- Absolute Value Decrease on Day 7 — -33.00; -37.10; -37.10 Absolute value units on a scale VAS
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Traumeel S ointment (Drug); Traumeel S gel (Drug); Diclofenac gel (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biologische Heilmittel Heel GmbH
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient's Assessment of Ankle Pain (VAS)- Absolute Value Decrease on Day 7 |
-33.00; -37.10; -37.10 | — |
| PRIMARY Change of the Foot and Ankle Ability Measurement (FAAM), Activity of Daily Living Subscale (ADL) From Baseline to Day 7 |
26.20; 26.20; 25.00 | — |
| PRIMARY Patient's Assessment of Ankle Pain (VAS)- Percentage Decrease on Day 7 |
-60.55; -71.10; -68.90 | — |
| SECONDARY FAAM ADL Subscale |
— | — |
| SECONDARY FAAM Sports Subscale |
— | — |
| SECONDARY Swelling ('Figure-of-eight') |
— | — |
| SECONDARY Physician's Assessment of Normal Function/Activity (5-point-scale) |
— | — |
| SECONDARY Time to Normal Function (Training/Sports) |
— | — |
| SECONDARY Global Judgment of Efficacy |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01066520). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.