Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Ankle Sprain

Completed · Phase 3 · Has a placebo group

Conditions studied: Acute Pain, Ankle Sprain

In brief

The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium topical patch in reducing acute pain due to mild to moderate ankle sprains when applied to the painful area.

Key facts

Study ID

NCT00869180

Run by

Cerimon Pharmaceuticals

People needed

219

Starts

2009-02-01

Expected to finish

2009-08-01

Last updated by the study team

2010-01-28

Who can join

Age: 17 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects 17 - 75 years of age
• Sustained recent, painful unilateral mild to moderate ankle sprain
• Meet baseline pain criterion

You may not qualify if…

• Open wound or infection at site of injury
• 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

Where it is running

• PPD — Austin, Texas, United States

Full record on ClinicalTrials.gov

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