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Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied 4 Times Daily in Subjects With Acute Ankle Sprain

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ClinicalTrials.gov Identifier: NCT01255423
Recruitment Status : Completed
First Posted : December 7, 2010
Results First Posted : October 4, 2012
Last Update Posted : October 4, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Ankle Sprain
Interventions Drug: Diclofenac sodium topical gel 1%
Drug: Placebo
Enrollment 206
Recruitment Details Study Start 30 Nov 2010 Study end 17 Juin 2011
Pre-assignment Details  
Arm/Group Title Diclofenac Sodium Topical Gel 1% Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 104 102
Completed 101 99
Not Completed 3 3
Reason Not Completed
Abnormal Laboratory value             3             2
Use of prohibited medications             0             1
Arm/Group Title Diclofenac Sodium Topical Gel 1% Placebo Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 104 102 206
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 104 participants 102 participants 206 participants
31.0  (13.1) 30.8  (13.9) 30.9  (13.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 102 participants 206 participants
Female
62
  59.6%
57
  55.9%
119
  57.8%
Male
42
  40.4%
45
  44.1%
87
  42.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 104 participants 102 participants 206 participants
104 102 206
18 years and above  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 104 participants 102 participants 206 participants
<=18 years 0 0 0
18 years and above 104 102 206
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:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 104 102
Mean (Standard Deviation)
Unit of Measure: mm
37.4  (25.2) 38.8  (24.1)
2.Secondary Outcome
Title Pain on Movement
Hide Description Pain on movement at 24 hours and 7 days assessed on a 100 mm visual analog scale with anchors at 0= "No pain" and 100= "Extreme pain"
Time Frame 24 hours and 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diclofenac Sodium Topical Gel 1% Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 104 102
Mean (Standard Deviation)
Unit of Measure: mm
24 hours 52.9  (22.5) 53.1  (22.6)
7 days 19.4  (23.1) 22  (23.5)
3.Secondary Outcome
Title Onset of Pain Relief
Hide Description Onset of perceptible pain relief
Time Frame 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:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 104 102
Median (Inter-Quartile Range)
Unit of Measure: Hour
2
(2 to 2.2)
2
(1.8 to 6.0)
4.Secondary Outcome
Title Tenderness
Hide Description Tenderness at 24 and 72 hours and 7 days. Change from baseline. Tenderness was measured by a calibrated algometer in order to quantify the pressure pain threshold, a measure of tenderness.
Time Frame Change from baseline at 24 and 72 hours, 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diclofenac Sodium Topical Gel 1% Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 104 102
Mean (Standard Deviation)
Unit of Measure: N/cm^2
Change from baseline at 24 Hours 2.3  (8.2) 1.3  (7.7)
Change from baseline at 72 Hours 6.4  (11.9) 5.5  (11.4)
Change from baseline at 7 Days 12.1  (13.3) 11.9  (10.6)
5.Secondary Outcome
Title Ankle Joint Function
Hide Description Ankle joint function score (Karlsson Scoring scale which ranges from 0 "worst possible score" to 90 "best possible score")at 24 and 72 hours and 7 days.
Time Frame 24 and 72 hours, 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diclofenac Sodium Topical Gel 1% Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 104 102
Mean (Standard Deviation)
Unit of Measure: Total score
24 Hours 30.1  (18.7) 30.7  (17.6)
72 Hours 47.2  (19.3) 46.1  (19.8)
7 days 68.8  (20.0) 66.4  (21.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diclofenac Sodium Topical Gel 1% Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
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   0/104 (0.00%)      0/102 (0.00%)    
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   11/104 (10.58%)      8/102 (7.84%)    
General disorders     
General disorders and administration site conditions  2  1/104 (0.96%)  1 1/102 (0.98%)  1
Hepatobiliary disorders     
Hepatobiliary disorders  2  1/104 (0.96%)  1 0/102 (0.00%)  0
Infections and infestations     
Infection and infestations  2  2/104 (1.92%)  2 0/102 (0.00%)  0
Injury, poisoning and procedural complications     
Injury poisoning and procedural complications  2  0/104 (0.00%)  0 1/102 (0.98%)  1
Musculoskeletal and connective tissue disorders     
Musculoskeletal and connective tissue disorder  2  2/104 (1.92%)  2 3/102 (2.94%)  3
Nervous system disorders     
Nervous Sytem disorders  1  5/104 (4.81%)  5 3/102 (2.94%)  3
Renal and urinary disorders     
Renal and urinary disorders  2  0/104 (0.00%)  0 1/102 (0.98%)  1
Reproductive system and breast disorders     
Reproductive system and breast disorders  2  1/104 (0.96%)  1 0/102 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Respiratory, thoracic and mediastinal disorders  2  1/104 (0.96%)  1 0/102 (0.00%)  0
Skin and subcutaneous tissue disorders     
Skin and subcutaneous tissue disorders  2  1/104 (0.96%)  1 3/102 (2.94%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
2
Term from vocabulary, MedDRA (Unspecified)
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
Name/Title: Clinical Project Leader
Organization: Novartis Consumer Health
Phone: 0041223635528
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01255423     History of Changes
Other Study ID Numbers: 197-P-320
First Submitted: December 1, 2010
First Posted: December 7, 2010
Results First Submitted: June 8, 2012
Results First Posted: October 4, 2012
Last Update Posted: October 4, 2012