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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
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.

NCT01054820
Pfizer
Completed
Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain

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[email protected]

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Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain
Multicenter, Open-Label Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain
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.
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Back Strain
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.
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%
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
123
March 2010
March 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01054820
K353-09-4001
B4811001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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