Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 81 of 345 for:    sprains and strains

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01066520
Recruitment Status : Completed
First Posted : February 10, 2010
Results First Posted : December 9, 2013
Last Update Posted : January 9, 2014
Sponsor:
Information provided by (Responsible Party):
Biologische Heilmittel Heel GmbH

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Sprain of Ankle
Interventions Drug: Traumeel S ointment
Drug: Traumeel S gel
Drug: Diclofenac gel
Enrollment 449
Recruitment Details 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.
Pre-assignment Details 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
Arm/Group Title Traumeel S Ointment Traumeel S Gel Diclofenac Gel
Hide Arm/Group Description 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, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing 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
Period Title: Overall Study
Started 143 140 137
Completed 143 140 137
Not Completed 0 0 0
Arm/Group Title Traumeel S Ointment Traumeel S Gel Diclofenac Gel Total
Hide Arm/Group Description Traumeel S Ointment 2g, 3 times daily topical during 14 days Traumeel S Gel 2g, 3 times daily topical during 14 days Diclofenac Gel 2g, 3 times daily topical during 14 days Total of all reporting groups
Overall Number of Baseline Participants 143 140 137 420
Hide Baseline Analysis Population Description
Analyzed ITT population
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 143 participants 140 participants 137 participants 420 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
143
 100.0%
140
 100.0%
137
 100.0%
420
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 143 participants 140 participants 137 participants 420 participants
Female
39
  27.3%
39
  27.9%
34
  24.8%
112
  26.7%
Male
104
  72.7%
101
  72.1%
103
  75.2%
308
  73.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Spain Number Analyzed 143 participants 140 participants 137 participants 420 participants
143 140 137 420
1.Primary Outcome
Title Patient's Assessment of Ankle Pain (VAS)- Absolute Value Decrease on Day 7
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Traumeel S Ointment Traumeel S Gel Diclofenac Gel
Hide Arm/Group Description:
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, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
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 Number of Participants Analyzed 143 140 137
Median (Inter-Quartile Range)
Unit of Measure: Absolute value units on a scale VAS
-33.00
(-45.40 to -23.70)
-37.10
(-50.00 to -27.30)
-37.10
(-47.40 to -26.80)
2.Primary Outcome
Title Change of the Foot and Ankle Ability Measurement (FAAM), Activity of Daily Living Subscale (ADL) From Baseline to Day 7
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Traumeel S Ointment Traumeel S Gel Diclofenac Gel
Hide Arm/Group Description:
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, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
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 Number of Participants Analyzed 143 140 137
Median (Inter-Quartile Range)
Unit of Measure: Scores on a scale
26.20
(16.70 to 35.70)
26.20
(16.70 to 36.90)
25.00
(14.60 to 34.50)
3.Primary Outcome
Title Patient's Assessment of Ankle Pain (VAS)- Percentage Decrease on Day 7
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Traumeel S Ointment Traumeel S Gel Diclofenac Gel
Hide Arm/Group Description:
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, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
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 Number of Participants Analyzed 143 140 137
Median (Inter-Quartile Range)
Unit of Measure: Percentage change in scale VAS
-60.55
(-85.70 to -42.90)
-71.10
(-84.85 to -48.40)
-68.90
(-83.60 to -48.95)
4.Secondary Outcome
Title FAAM ADL Subscale
Hide Description [Not Specified]
Time Frame Day 1 to 4, 14, 42
Outcome Measure Data Not Reported
5.Secondary Outcome
Title FAAM Sports Subscale
Hide Description [Not Specified]
Time Frame Day 1 to 4, 7, 14, 42
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Swelling ('Figure-of-eight')
Hide Description [Not Specified]
Time Frame Day 1 to 4,7,14
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Physician's Assessment of Normal Function/Activity (5-point-scale)
Hide Description [Not Specified]
Time Frame Day 1 to 4, 7, 14, 42
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Time to Normal Function (Training/Sports)
Hide Description [Not Specified]
Time Frame Day 1 to 4, 7, 14, 42
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Global Judgment of Efficacy
Hide Description [Not Specified]
Time Frame Day 14
Outcome Measure Data Not Reported
Time Frame Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Traumeel S Ointment Traumeel S Gel Diclofenac Gel
Hide Arm/Group Description 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, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing 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
All-Cause Mortality
Traumeel S Ointment Traumeel S Gel Diclofenac Gel
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Traumeel S Ointment Traumeel S Gel Diclofenac Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/152 (0.00%)      0/148 (0.00%)      0/147 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Traumeel S Ointment Traumeel S Gel Diclofenac Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/152 (7.24%)      15/148 (10.14%)      8/147 (5.44%)    
General disorders       
Pain  1  1/152 (0.66%)  2 0/148 (0.00%)  0 0/147 (0.00%)  0
Swelling  1  0/152 (0.00%)  0 0/148 (0.00%)  0 2/147 (1.36%)  3
Infections and infestations       
Influenza  1  0/152 (0.00%)  0 1/148 (0.68%)  1 0/147 (0.00%)  0
Nasopharingitis  1  0/152 (0.00%)  0 2/148 (1.35%)  2 1/147 (0.68%)  1
Injury, poisoning and procedural complications       
Joint injury  1  1/152 (0.66%)  1 0/148 (0.00%)  0 0/147 (0.00%)  0
Joint sprain  1  1/152 (0.66%)  1 1/148 (0.68%)  1 1/147 (0.68%)  1
Musculoskeletal and connective tissue disorders       
Back pain  1  0/152 (0.00%)  0 2/148 (1.35%)  2 0/147 (0.00%)  0
Nervous system disorders       
Headache  1  3/152 (1.97%)  7 5/148 (3.38%)  5 1/147 (0.68%)  1
Hypoasthesia  1  1/152 (0.66%)  1 0/148 (0.00%)  0 0/147 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Oropharingeal pain  1  1/152 (0.66%)  1 1/148 (0.68%)  1 1/147 (0.68%)  1
Skin and subcutaneous tissue disorders       
Dry skin  1  0/152 (0.00%)  0 1/148 (0.68%)  1 0/147 (0.00%)  0
Erythema  1  3/152 (1.97%)  4 0/148 (0.00%)  0 1/147 (0.68%)  1
Pruritus  1  2/152 (1.32%)  2 2/148 (1.35%)  2 1/147 (0.68%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Istvan Zatik
Organization: Biologische Heilmittel Heel GmbH
Phone: +4972215013192
Responsible Party: Biologische Heilmittel Heel GmbH
ClinicalTrials.gov Identifier: NCT01066520     History of Changes
Other Study ID Numbers: TRS-ESP
2008-007939-41 ( EudraCT Number )
First Submitted: February 9, 2010
First Posted: February 10, 2010
Results First Submitted: February 18, 2013
Results First Posted: December 9, 2013
Last Update Posted: January 9, 2014