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

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NCT01054820

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1-800-718-1021
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1-800-718-1021

By email

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acute Back Strain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Participants in the study must:

1. have acute, non-radicular back strain with onset up to 10 days before the first visit

2. have intact, non-damaged skin at the proposed patch application site

3. be untreated or unresponsive to conservative pain treatment regimens and/or opioids

4. have a minimum pain intensity score of four (4) or more on a scale of 1-10 (a rating of zero (0) being "no pain" and a rating of ten (10) being "pain as bad as you can imagine")

5. have a normal neurologic examination

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


Participants may not be in the study if they:


1. have had surgery or other chronic pain condition within 3 months before first
treatment


2. have back pain radiating below the knee at time of enrollment


3. have neuropathic pain or have been treated with gabapentin or pregabalin for
neuropathy


4. are being treated for or are known to currently have kidney or liver disease


5. have certain other diseases or are using certain types of other drugs.

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Acute Back StrainStudy to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain NCT01054820
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain
Official Title  ICMJE Multicenter, Open-Label Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain
Brief Summary Although approved for minor strains, sprains and contusions, FLECTOR Patch has not been studied extensively in the setting of acute back strain. This study is being conducted as an initial step in demonstrating the benefit of FLECTOR Patch specifically for back strain. In particular, this study is expected to provide information about the amount of improvement in back strain among subjects using the FLECTOR Patch, which may then be used to inform subsequent studies.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Back Strain
Intervention  ICMJE Drug: FLECTOR® Patch (diclofenac epolamine topical patch) 1.3%
One FLECTOR Patch applied to the most painful area on the subject's back every 12 hours for up to 14 days.
Study Arms  ICMJE Experimental: FLECTORA Patch (diclofenac epolamine topical patch) 1.3%
One patch applied every 12 hours
Intervention: Drug: FLECTOR® Patch (diclofenac epolamine topical patch) 1.3%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2010)		123
Original Estimated Enrollment  ICMJE
 (submitted: January 20, 2010)		100
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Participants in the study must:

  1. have acute, non-radicular back strain with onset up to 10 days before the first visit
  2. have intact, non-damaged skin at the proposed patch application site
  3. be untreated or unresponsive to conservative pain treatment regimens and/or opioids
  4. have a minimum pain intensity score of four (4) or more on a scale of 1-10 (a rating of zero (0) being "no pain" and a rating of ten (10) being "pain as bad as you can imagine")
  5. have a normal neurologic examination

Exclusion Criteria:

Participants may not be in the study if they:

  1. have had surgery or other chronic pain condition within 3 months before first treatment
  2. have back pain radiating below the knee at time of enrollment
  3. have neuropathic pain or have been treated with gabapentin or pregabalin for neuropathy
  4. are being treated for or are known to currently have kidney or liver disease
  5. have certain other diseases or are using certain types of other drugs.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01054820
Other Study ID Numbers  ICMJE K353-09-4001
B4811001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP