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Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Ankle Sprain

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ClinicalTrials.gov Identifier: NCT01272934
Recruitment Status : Completed
First Posted : January 10, 2011
Results First Posted : January 15, 2013
Last Update Posted : January 24, 2013
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acute Ankle Sprain
Interventions Drug: Diclofenac Sodium
Other: Placebo
Enrollment 205
Recruitment Details Study Start 18 January 2011 Study end 23 August 2011
Pre-assignment Details  
Arm/Group Title Diclofenac Sodium Topical Gel 1% Placebo
Hide Arm/Group Description

Diclofenac sodium topical gel 1%

Diclofenac Sodium : Topical gel 1%-4 times daily

Placebo : Topical gel-4 times daily
Period Title: Overall Study
Started 102 103
Completed 102 101
Not Completed 0 2
Reason Not Completed
Adverse Event             0             1
Abnormal Laboratory Value             0             1
Arm/Group Title Diclofenac Sodium Topical Gel 1% Placebo Total
Hide Arm/Group Description

Diclofenac sodium topical gel 1%

Diclofenac Sodium : Topical gel 1%-4 times daily

Placebo : Topical gel-4 times daily Total of all reporting groups
Overall Number of Baseline Participants 102 103 205
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants 103 participants 205 participants
32.5  (12.0) 30.5  (10.8) 31.5  (11.4)
[1]
Measure Description: Age : 18 years and over
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 103 participants 205 participants
Female
49
  48.0%
55
  53.4%
104
  50.7%
Male
53
  52.0%
48
  46.6%
101
  49.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 102 participants 103 participants 205 participants
102 103 205
1.Primary Outcome
Title Pain on Movement
Hide Description Pain on Movement at 72 hours assessed on a 100 mm visual analog scale with anchors at 0="No pain" and 100= "Extreme pain"
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diclofenac Sodium Topical Gel 1% Placebo
Hide Arm/Group Description:

Diclofenac sodium topical gel 1%

Diclofenac Sodium : Topical gel 1%-4 times daily

Placebo : Topical gel-4 times daily
Overall Number of Participants Analyzed 102 103
Mean (Standard Deviation)
Unit of Measure: mm
25.6  (15.9) 61.2  (16.6)
2.Secondary Outcome
Title Onset of Pain Relief
Hide Description Onset of perceptible pain relief.
Time Frame On day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diclofenac Sodium Topical Gel 1% Placebo
Hide Arm/Group Description:

Diclofenac sodium topical gel 1%

Diclofenac Sodium : Topical gel 1%-4 times daily

[Not Specified]
Overall Number of Participants Analyzed 102 103
Median (Inter-Quartile Range)
Unit of Measure: Hours
4
(2 to 6)
NA [1] 
(NA to NA)
[1]
Onset of Pain relief was not achieved for the first quartile within the given time frame in the placebo group
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diclofenac Sodium Topical Gel 1% Placebo
Hide Arm/Group Description

Diclofenac sodium topical gel 1%

Diclofenac Sodium : Topical gel 1%-4 times daily

Placebo : Topical gel-4 times daily
All-Cause Mortality
Diclofenac Sodium Topical Gel 1% Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Diclofenac Sodium Topical Gel 1% Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/102 (0.00%)      1/103 (0.97%)    
Injury, poisoning and procedural complications     
Distorsion of wrist and ligament rupture  1  0/102 (0.00%)  0 1/103 (0.97%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Diclofenac Sodium Topical Gel 1% Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/102 (5.88%)      3/103 (2.91%)    
Gastrointestinal disorders     
Gastrointestinal disorders  1  1/102 (0.98%)  1 0/103 (0.00%)  0
Hepatobiliary disorders     
Hepatobiliary disorders  1  0/102 (0.00%)  0 1/103 (0.97%)  1
Infections and infestations     
Infections and infestations  1  3/102 (2.94%)  3 2/103 (1.94%)  2
Nervous system disorders     
Nervous system disorders  1  1/102 (0.98%)  1 0/103 (0.00%)  0
Skin and subcutaneous tissue disorders     
Skin and subcutaneous tissue disorders  1  1/102 (0.98%)  1 0/103 (0.00%)  0
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.
Preliminary agreement between Novartis Consumer Health and the investigator
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Project Leader
Organization: Novartis Consumer Health
Phone: 0041223635228
Layout table for additonal information
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01272934     History of Changes
Other Study ID Numbers: VOSG-P-318
First Submitted: January 7, 2011
First Posted: January 10, 2011
Results First Submitted: August 7, 2012
Results First Posted: January 15, 2013
Last Update Posted: January 24, 2013