- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00869063
Diclofenac Patch for the Treatment of Acute Pain Due to Mild to Moderate Wrist Sprain, Strain or Contusion (WIND)
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78704
- PPD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo Patch
|
Matching placebo patch, containing identical constituents to the active drug arm except for diclofenac sodium; applied once daily for 7 days
|
Experimental: Diclofenac Sodium Patch
|
Topical 1% diclofenac sodium patch, applied once daily for 7 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in average pain during daily activity
Time Frame: Day 3
|
Day 3
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in average pain during daily activity
Time Frame: Day 7
|
Day 7
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Wounds and Injuries
- Wounds, Nonpenetrating
- Acute Pain
- Sprains and Strains
- Contusions
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Diclofenac
Other Study ID Numbers
- DCF-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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