Diclofenac Patch for the Treatment of Acute Pain Due to Mild to Moderate Wrist Sprain, Strain or Contusion (WIND)

Cerimon Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Acute Pain

Treatments: Drug: Matching Placebo Patch; Drug: Diclofenac Sodium Patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT00869063

DCF-005

Details and patient eligibility

About

The purpose of the 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 wrist sprain, strain or contusion when applied to the painful area.

Full description

This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with a mild to moderate wrist sprain, strain or contusion.

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.

Enrollment: 214 patients

Sex: All

Ages: 17 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Open wound or infection at the site of injury
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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214 participants in 2 patient groups, including a placebo group

Diclofenac Sodium Patch

Experimental group

Treatment:

Drug: Diclofenac Sodium Patch

Placebo Patch

Placebo Comparator group

Treatment:

Drug: Matching Placebo Patch