Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Ankle Sprain
NCT ID: NCT00869180
Last Updated: 2010-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
219 participants
INTERVENTIONAL
2009-02-28
2009-08-31
Brief Summary
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Detailed Description
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Eligible patients will be randomized (in a 1:1 ratio) to receive double-blind treatment with either the diclofenac topical patch or a matching placebo patch to be applied once daily for 7 days. Patients will return to the clinic for assessments on Day 3 and Day 7; a follow-up assessment will be conducted on Day 14. Patients will complete an electronic diary in which assessments including pain intensity, pain relief and functional disability will be recorded twice daily. Ratings of the quality of sleep will be recorded in the diary each morning, and the use of study treatment and rescue medication will be recorded in the diary each day.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Diclofenac Sodium Patch
Diclofenac Sodium
Topical diclofenac patch applied once daily to area of pain
Topical Placebo Patch
Matching Placebo Patch
Matching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; applied once daily
Interventions
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Diclofenac Sodium
Topical diclofenac patch applied once daily to area of pain
Matching Placebo Patch
Matching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; applied once daily
Eligibility Criteria
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Inclusion Criteria
* Sustained recent, painful unilateral mild to moderate ankle sprain
* Meet baseline pain criterion
Exclusion Criteria
* Evidence of severe injury or ankle fracture
* Use of oral NSAIDs or opioids within 12 - 24 hours of injury
* Presence or history of peptic ulcers or GI bleeding
* A history of intolerance to NSAIDs, acetaminophen, adhesives
* Positive pregnancy test
* Positive drug screen
17 Years
75 Years
ALL
No
Sponsors
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PPD Development, LP
INDUSTRY
Cerimon Pharmaceuticals
INDUSTRY
Responsible Party
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Cerimon Pharmaceuticals
Locations
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PPD
Austin, Texas, United States
Countries
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Other Identifiers
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DCF-004
Identifier Type: -
Identifier Source: org_study_id