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

C

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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