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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00869063
First Posted: March 25, 2009
Last Update Posted: January 28, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
PPD
Information provided by:
Cerimon Pharmaceuticals
  Purpose
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.

Condition Intervention Phase
Acute Pain Drug: Diclofenac Sodium Patch Drug: Matching Placebo Patch Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Cerimon Pharmaceuticals:

Primary Outcome Measures:
  • Change in average pain during daily activity [ Time Frame: Day 3 ]

Secondary Outcome Measures:
  • Change in average pain during daily activity [ Time Frame: Day 7 ]

Enrollment: 214
Study Start Date: February 2009
Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diclofenac Sodium Patch Drug: Diclofenac Sodium Patch
Topical 1% diclofenac sodium patch, applied once daily for 7 days
Placebo Comparator: Placebo Patch Drug: Matching Placebo Patch
Matching placebo patch, containing identical constituents to the active drug arm except for diclofenac sodium; applied once daily for 7 days

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00869063


Locations
United States, Texas
PPD
Austin, Texas, United States, 78704
Sponsors and Collaborators
Cerimon Pharmaceuticals
PPD
  More Information

Responsible Party: Shaily J. Reichert, V.P. of Clinical Development, Cerimon Pharmaceuticals, inc.
ClinicalTrials.gov Identifier: NCT00869063     History of Changes
Other Study ID Numbers: DCF-005
First Submitted: March 24, 2009
First Posted: March 25, 2009
Last Update Posted: January 28, 2010
Last Verified: January 2010

Keywords provided by Cerimon Pharmaceuticals:
wrist
sprain
strain
contusion
diclofenac
patch
acute pain
acute pain due to mild to moderate wrist sprain, strain or contusion

Additional relevant MeSH terms:
Sprains and Strains
Acute Pain
Contusions
Wounds and Injuries
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Wounds, Nonpenetrating
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action