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Trial record 78 of 347 for:    sprains and strains

Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain

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ClinicalTrials.gov Identifier: NCT00955513
Recruitment Status : Completed
First Posted : August 10, 2009
Results First Posted : January 26, 2011
Last Update Posted : April 20, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Grade I/II Ankle Sprain
Interventions Drug: diclofenac diethylamine gel 2.32%
Drug: Placebo
Enrollment 242
Recruitment Details 6 centers in Germany. Recruitment commenced in July 2009 and completed in December 2009.
Pre-assignment Details  
Arm/Group Title Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day Placebo. Applied 3 Times a Day.
Hide Arm/Group Description drug drug placebo
Period Title: Overall Study
Started 80 80 82
Completed 79 78 79
Not Completed 1 2 3
Arm/Group Title Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day Placebo. Applied 3 Times a Day. Total
Hide Arm/Group Description drug drug placebo Total of all reporting groups
Overall Number of Baseline Participants 80 80 82 242
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 80 participants 82 participants 242 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
80
 100.0%
77
  96.3%
81
  98.8%
238
  98.3%
>=65 years
0
   0.0%
3
   3.8%
1
   1.2%
4
   1.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants 80 participants 82 participants 242 participants
30.9  (11.4) 32.2  (13.7) 34.0  (12.9) 32.4  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 80 participants 82 participants 242 participants
Female
31
  38.8%
31
  38.8%
28
  34.1%
90
  37.2%
Male
49
  61.3%
49
  61.3%
54
  65.9%
152
  62.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 80 participants 80 participants 82 participants 242 participants
80 80 82 242
1.Primary Outcome
Title Measure: Pain on Movement on Day 5 (Change From Baseline).
Hide Description Visual analog scale (0 to 100 mm) A greater change from baseline equates to a better outcome.
Time Frame baseline and day 5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day Placebo. Applied 3 Times a Day.
Hide Arm/Group Description:
drug
drug
placebo
Overall Number of Participants Analyzed 80 80 82
Mean (Standard Deviation)
Unit of Measure: mm
49.1  (19.3) 49.7  (21.5) 25.4  (14.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day Placebo. Applied 3 Times a Day.
Hide Arm/Group Description drug drug placebo
All-Cause Mortality
Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day Placebo. Applied 3 Times a Day.
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day Placebo. Applied 3 Times a Day.
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/80 (0.00%)      0/80 (0.00%)      0/82 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day Placebo. Applied 3 Times a Day.
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/80 (0.00%)      1/80 (1.25%)      1/82 (1.22%)    
Nervous system disorders       
Headache  1  0/80 (0.00%)  0 1/80 (1.25%)  1 1/82 (1.22%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Clinical Project Leader Pain category
Organization: Novartis Consumer Health
Phone: +41223635528
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00955513     History of Changes
Other Study ID Numbers: VOPO-P-307
First Submitted: August 7, 2009
First Posted: August 10, 2009
Results First Submitted: December 1, 2010
Results First Posted: January 26, 2011
Last Update Posted: April 20, 2012