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Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01054820
First received: January 20, 2010
Last updated: July 10, 2012
Last verified: July 2012
Results First Received: July 10, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acute Back Strain
Intervention: Drug: FLECTOR® Patch (diclofenac epolamine topical patch) 1.3%

  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
No text entered.

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
FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.

Participant Flow:   Overall Study
    FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.  
STARTED     123  
COMPLETED     121  
NOT COMPLETED     2  
Withdrawal by Subject                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.

Baseline Measures
    FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.  
Number of Participants  
[units: participants]
  123  
Age  
[units: years]
Mean ± Standard Deviation
  38.8  ± 12.4  
Gender  
[units: participants]
 
Female     60  
Male     63  



  Outcome Measures
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1.  Primary:   Mean Change From Baseline to End of Treatment (EOT) in Response to Modified Brief Pain Inventory (mBPI) Question 5: Average Pain Over the Last 24 Hours   [ Time Frame: Baseline, End of Treatment (last visit up to Day 15) ]

2.  Secondary:   Number of Participants With Change From Baseline (Bsl) to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 1: Pain Other Than Everyday Kind of Pain   [ Time Frame: Baseline, End of Treatment (last visit up to Day 15) ]

3.  Secondary:   Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 3: Pain at Its Worst in the Last 24 Hours   [ Time Frame: Baseline, End of Treatment (last visit up to Day 15) ]

4.  Secondary:   Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 4: Pain at Its Least in the Last 24 Hours   [ Time Frame: Baseline, End of Treatment (last visit up to Day 15) ]

5.  Secondary:   Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 6: Pain Right Now   [ Time Frame: Baseline, End of Treatment (last visit up to Day 15) ]

6.  Secondary:   Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 8: Percent Reduction in Pain From Baseline   [ Time Frame: Baseline, End of Treatment (last visit up to Day 15) ]

7.  Secondary:   Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Participant   [ Time Frame: End of Treatment (up to Day 15) ]

8.  Secondary:   Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Investigator   [ Time Frame: End of Treatment (up to Day 15) ]

9.  Secondary:   Mean Change From Baseline to EOT in Beck Depression Inventory® Il   [ Time Frame: Baseline, End of Treatment (last visit up to Day 15) ]

10.  Secondary:   Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by Participant   [ Time Frame: End of Treatment (last visit up to Day 15) ]

11.  Secondary:   Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by the Investigator   [ Time Frame: End of Treatment (last visit up to Day 15) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01054820     History of Changes
Other Study ID Numbers: K353-09-4001, B4811001
Study First Received: January 20, 2010
Results First Received: July 10, 2012
Last Updated: July 10, 2012
Health Authority: United States: Institutional Review Board