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

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a Diclofenac Sodium Patch for the Topical Treatment of Acute Pain Due to Mild to Moderate Wrist Sprain, Strain or Contusion

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00869063

Acronym

WIND

Enrollment

214

Registered

2009-03-25

Start date

2009-02-28

Completion date

2009-09-30

Last updated

2010-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain

Keywords

wrist, sprain, strain, contusion, diclofenac, patch, acute pain, acute pain due to mild to moderate wrist sprain, strain or contusion

Brief summary

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.

Detailed 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.

Interventions

DRUGDiclofenac Sodium Patch

Topical 1% diclofenac sodium patch, applied once daily for 7 days

DRUGMatching Placebo Patch

Matching placebo patch, containing identical constituents to the active drug arm except for diclofenac sodium; applied once daily for 7 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

17 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Change in average pain during daily activity	Day 3

Secondary

Measure	Time frame
Change in average pain during daily activity	Day 7

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026