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Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Blunt Trauma Injuries

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01272947
First received: January 7, 2011
Last updated: December 6, 2012
Last verified: December 2012
History of Changes
Results First Received: July 17, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Acute Blunt Soft Tissue Injuries/Contusions
Interventions: Drug: Diclofenac sodium
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Diclofenac Sodium Topical Gel 1% No text entered.
Placebo No text entered.

Participant Flow:   Overall Study
    Diclofenac Sodium Topical Gel 1%     Placebo  
STARTED     104     100  
COMPLETED     102     98  
NOT COMPLETED     2     2  
Abnormal Laboratory Value                 2                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Diclofenac Sodium Topical Gel 1% No text entered.
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
    Diclofenac Sodium Topical Gel 1%     Placebo     Total  
Number of Participants  
[units: participants]
 		  104     100     204  
Age  
[units: years]
Mean ± Standard Deviation 		     
Unit : years     29.4  ± 9.6     31.4  ± 12.1     30.4  ± 10.9  
Gender  
[units: participants]
 		     
Female     55     48     103  
Male     49     52     101  
Region of Enrollment  
[units: participants]
 		     
Germany     104     100     204  



  Outcome Measures
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1.  Primary:   Pain on Movement   [ Time Frame: VAS Score at 24 hours ]
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2.  Secondary:   Onset of Pain Relief   [ Time Frame: From randomization to end of day 1 ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Clinical Project Leader
Organization: Novartis Consumer Health S.A.
phone: +41 22 3635528


No publications provided


Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01272947     History of Changes
Other Study ID Numbers: VOSG-P-319
Study First Received: January 7, 2011
Results First Received: July 17, 2012
Last Updated: December 6, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration