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

History of Changes

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: FLECTORÂ® 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
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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
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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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

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: 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

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