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Efficacy and Safety of Diclofenac Potassium 25 mg Tablet Taken Three Times Daily in Subjects With Acute Joint Pain

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ClinicalTrials.gov Identifier: NCT01666197
Recruitment Status : Completed
First Posted : August 16, 2012
Results First Posted : March 27, 2014
Last Update Posted : April 17, 2014
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 Ankle Sprain
Interventions Drug: diclofenac potassium 25 mg tablet
Drug: placebo
Enrollment 100
Recruitment Details Four centers in Germany recruited patients from 22 Aug 2012 to 27 Jan 2013
Pre-assignment Details  
Arm/Group Title Diclofenac Potassium 25 mg Tablet Placebo
Hide Arm/Group Description diclofenac potassium 25 mg tablet: diclofenac potassium 25 mg tablet placebo: placebo
Period Title: Overall Study
Started 50 50
Completed 50 50
Not Completed 0 0
Arm/Group Title Diclofenac Potassium 25 mg Tablet Placebo Total
Hide Arm/Group Description diclofenac potassium 25 mg tablet: diclofenac potassium 25 mg tablet placebo: placebo Total of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 50 participants 100 participants
30.7  (13.4) 33.2  (12.2) 32.0  (12.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female
23
  46.0%
24
  48.0%
47
  47.0%
Male
27
  54.0%
26
  52.0%
53
  53.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
50
 100.0%
50
 100.0%
100
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 50 participants 50 participants 100 participants
50 50 100
1.Primary Outcome
Title Pain on Movement
Hide Description Change on a Visual analog scale from Baseline. Pain on Movement at 48 hours assessed on a 100 mm visual analog scale with anchors at 0="No pain" and 100= "Extreme pain"
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diclofenac Potassium 25 mg Tablet Placebo
Hide Arm/Group Description:
diclofenac potassium 25 mg tablet: diclofenac potassium 25 mg tablet
placebo: placebo
Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: mm
31.3  (18.8) 59.2  (12.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diclofenac Potassium 25 mg Tablet Placebo
Hide Arm/Group Description diclofenac potassium 25 mg tablet: diclofenac potassium 25 mg tablet placebo: placebo
All-Cause Mortality
Diclofenac Potassium 25 mg Tablet Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Diclofenac Potassium 25 mg Tablet Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/50 (0.00%)      0/50 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Diclofenac Potassium 25 mg Tablet Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/50 (2.00%)      3/50 (6.00%)    
General disorders     
Feeling hot * 1  0/50 (0.00%)  0 1/50 (2.00%)  1
Nervous system disorders     
Headache * 1  0/50 (0.00%)  0 2/50 (4.00%)  2
Respiratory, thoracic and mediastinal disorders     
Rhinorrhoea * 1  1/50 (2.00%)  1 0/50 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
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 SA
Phone: 41223635293
Layout table for additonal information
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01666197    
Other Study ID Numbers: 853-P-401
First Submitted: August 14, 2012
First Posted: August 16, 2012
Results First Submitted: February 12, 2014
Results First Posted: March 27, 2014
Last Update Posted: April 17, 2014