Diclofenac Patch for the Treatment of Acute Pain Due to Mild to Moderate Wrist Sprain, Strain or Contusion
NCT ID: NCT00869063
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
214 participants
INTERVENTIONAL
2009-02-28
2009-09-30
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 to 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 also 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 Patch
Topical 1% diclofenac sodium patch, applied once daily for 7 days
Placebo Patch
Matching Placebo Patch
Matching placebo patch, containing identical constituents to the active drug arm except for diclofenac sodium; applied once daily for 7 days
Interventions
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Diclofenac Sodium Patch
Topical 1% diclofenac sodium patch, applied once daily for 7 days
Matching Placebo Patch
Matching placebo patch, containing identical constituents to the active drug arm except for diclofenac sodium; applied once daily for 7 days
Eligibility Criteria
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Inclusion Criteria
* Sustained recent, painful unilateral mild to moderate wrist sprain, strain or contusion
* Meet baseline pain criterion
Exclusion Criteria
* Severe wrist injury or wrist fracture
* Presence or history of hand, wrist or forearm nerve impingement or palsies
* Use of NSAIDs or opioids within 12 - 24 hours of wrist injury
* Presence or history of peptic ulcers or GI bleeding
* 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, inc.
Locations
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PPD
Austin, Texas, United States
Countries
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Other Identifiers
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DCF-005
Identifier Type: -
Identifier Source: org_study_id