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

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.
 
ClinicalTrials.gov Identifier: NCT00869063
Recruitment Status : Completed
First Posted : March 25, 2009
Last Update Posted : January 28, 2010
Sponsor:
Collaborator:
PPD
Information provided by:
Cerimon Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE March 24, 2009
First Posted Date  ICMJE March 25, 2009
Last Update Posted Date January 28, 2010
Study Start Date  ICMJE February 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2009)
Change in average pain during daily activity [ Time Frame: Day 3 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2009)
Change in average pain during daily activity [ Time Frame: Day 7 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diclofenac Patch for the Treatment of Acute Pain Due to Mild to Moderate Wrist Sprain, Strain or Contusion
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Pain
Intervention  ICMJE
  • Drug: Diclofenac Sodium Patch
    Topical 1% diclofenac sodium patch, applied once daily for 7 days
  • 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
Study Arms  ICMJE
  • Experimental: Diclofenac Sodium Patch
    Intervention: Drug: Diclofenac Sodium Patch
  • Placebo Comparator: Placebo Patch
    Intervention: Drug: Matching Placebo Patch
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 26, 2010)
214
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2009)
208
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00869063
Other Study ID Numbers  ICMJE DCF-005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shaily J. Reichert, V.P. of Clinical Development, Cerimon Pharmaceuticals, inc.
Study Sponsor  ICMJE Cerimon Pharmaceuticals
Collaborators  ICMJE PPD
Investigators  ICMJE Not Provided
PRS Account Cerimon Pharmaceuticals
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP