Trial Outcomes & Findings for TAASS-Traumeel Ointment and Gel Compared With a Topical NSAID in Athletes With Acute Ankle Sprain (NCT NCT01066520)
NCT ID: NCT01066520
Last Updated: 2014-01-09
Results Overview
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.
COMPLETED
PHASE3
449 participants
From baseline (day 1) visit to day 7
2014-01-09
Participant Flow
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.
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
Participant milestones
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
143
|
140
|
137
|
|
Overall Study
COMPLETED
|
143
|
140
|
137
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TAASS-Traumeel Ointment and Gel Compared With a Topical NSAID in Athletes With Acute Ankle Sprain
Baseline characteristics by cohort
| Measure |
Traumeel S Ointment
n=143 Participants
Traumeel S Ointment 2g, 3 times daily topical during 14 days
|
Traumeel S Gel
n=140 Participants
Traumeel S Gel 2g, 3 times daily topical during 14 days
|
Diclofenac Gel
n=137 Participants
Diclofenac Gel 2g, 3 times daily topical during 14 days
|
Total
n=420 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
143 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
420 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
104 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
308 Participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
143 participants
n=5 Participants
|
140 participants
n=7 Participants
|
137 participants
n=5 Participants
|
420 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From baseline (day 1) visit to day 7Population: 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.
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.
Outcome measures
| Measure |
Traumeel S Ointment
n=143 Participants
Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
|
Traumeel S Gel
n=140 Participants
Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
|
Diclofenac Gel
n=137 Participants
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
|
|---|---|---|---|
|
Patient's Assessment of Ankle Pain (VAS)- Absolute Value Decrease on Day 7
|
-33.00 Absolute value units on a scale VAS
Interval -45.4 to -23.7
|
-37.10 Absolute value units on a scale VAS
Interval -50.0 to -27.3
|
-37.10 Absolute value units on a scale VAS
Interval -47.4 to -26.8
|
PRIMARY outcome
Timeframe: Day 1 to day 7Population: 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.
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.
Outcome measures
| Measure |
Traumeel S Ointment
n=143 Participants
Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
|
Traumeel S Gel
n=140 Participants
Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
|
Diclofenac Gel
n=137 Participants
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
|
|---|---|---|---|
|
Change of the Foot and Ankle Ability Measurement (FAAM), Activity of Daily Living Subscale (ADL) From Baseline to Day 7
|
26.20 Scores on a scale
Interval 16.7 to 35.7
|
26.20 Scores on a scale
Interval 16.7 to 36.9
|
25.00 Scores on a scale
Interval 14.6 to 34.5
|
PRIMARY outcome
Timeframe: From baseline (day 1) visit to day 7Pain 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.
Outcome measures
| Measure |
Traumeel S Ointment
n=143 Participants
Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
|
Traumeel S Gel
n=140 Participants
Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
|
Diclofenac Gel
n=137 Participants
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
|
|---|---|---|---|
|
Patient's Assessment of Ankle Pain (VAS)- Percentage Decrease on Day 7
|
-60.55 Percentage change in scale VAS
Interval -85.7 to -42.9
|
-71.10 Percentage change in scale VAS
Interval -84.85 to -48.4
|
-68.90 Percentage change in scale VAS
Interval -83.6 to -48.95
|
SECONDARY outcome
Timeframe: Day 1 to 4, 14, 42Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 to 4, 7, 14, 42Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 to 4,7,14Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 to 4, 7, 14, 42Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 to 4, 7, 14, 42Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 14Outcome measures
Outcome data not reported
Adverse Events
Traumeel S Ointment
Traumeel S Gel
Diclofenac Gel
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Traumeel S Ointment
n=152 participants at risk
Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
|
Traumeel S Gel
n=148 participants at risk
Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
|
Diclofenac Gel
n=147 participants at risk
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
|
|---|---|---|---|
|
General disorders
Pain
|
0.66%
1/152 • Number of events 2 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
0.00%
0/148 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
0.00%
0/147 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
|
General disorders
Swelling
|
0.00%
0/152 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
0.00%
0/148 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
1.4%
2/147 • Number of events 3 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
|
Infections and infestations
Influenza
|
0.00%
0/152 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
0.68%
1/148 • Number of events 1 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
0.00%
0/147 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
|
Infections and infestations
Nasopharingitis
|
0.00%
0/152 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
1.4%
2/148 • Number of events 2 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
0.68%
1/147 • Number of events 1 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.66%
1/152 • Number of events 1 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
0.00%
0/148 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
0.00%
0/147 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.66%
1/152 • Number of events 1 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
0.68%
1/148 • Number of events 1 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
0.68%
1/147 • Number of events 1 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/152 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
1.4%
2/148 • Number of events 2 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
0.00%
0/147 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
|
Nervous system disorders
Headache
|
2.0%
3/152 • Number of events 7 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
3.4%
5/148 • Number of events 5 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
0.68%
1/147 • Number of events 1 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
|
Nervous system disorders
Hypoasthesia
|
0.66%
1/152 • Number of events 1 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
0.00%
0/148 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
0.00%
0/147 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharingeal pain
|
0.66%
1/152 • Number of events 1 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
0.68%
1/148 • Number of events 1 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
0.68%
1/147 • Number of events 1 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/152 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
0.68%
1/148 • Number of events 1 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
0.00%
0/147 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.0%
3/152 • Number of events 4 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
0.00%
0/148 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
0.68%
1/147 • Number of events 1 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.3%
2/152 • Number of events 2 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
1.4%
2/148 • Number of events 2 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
0.68%
1/147 • Number of events 1 • Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60