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Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Ankle Sprain (SUPPORT 2)

This study has been completed.
Sponsor:
Collaborator:
PPD
Information provided by:
Cerimon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00869180
First received: March 24, 2009
Last updated: January 26, 2010
Last verified: January 2010

March 24, 2009
January 26, 2010
February 2009
June 2009   (final data collection date for primary outcome measure)
Change in average pain during daily activity at Day 3 [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00869180 on ClinicalTrials.gov Archive Site
Change in average pain during daily activity at Day 7 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Ankle Sprain
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 Ankle Sprain

The primary purpose of this 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 ankle sprains when applied to the painful area.

This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with mild or moderate ankle sprains.

Eligible patients will be randomized (in a 1:1 ratio) to receive double-blind treatment with 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 be recorded in the diary each morning, and the use of study treatment and rescue medication will be recorded in the diary each day.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Acute Pain
  • Ankle Sprain
  • Drug: Diclofenac Sodium
    Topical diclofenac patch applied once daily to area of pain
  • Drug: Matching Placebo Patch
    Matching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; applied once daily
  • Experimental: Diclofenac Sodium Patch
    Intervention: Drug: Diclofenac Sodium
  • Placebo Comparator: Topical Placebo Patch
    Intervention: Drug: Matching Placebo Patch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
219
August 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female subjects 17 - 75 years of age
  • Sustained recent, painful unilateral mild to moderate ankle sprain
  • Meet baseline pain criterion

Exclusion Criteria:

  • Open wound or infection at site of injury
  • Evidence of severe injury or ankle fracture
  • Use of oral NSAIDs or opioids within 12 - 24 hours of injury
  • Presence or history of peptic ulcers or GI bleeding
  • A history of intolerance to NSAIDs, acetaminophen, adhesives
  • Positive pregnancy test
  • Positive drug screen
Both
17 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00869180
DCF-004
No
Shaily J. Reichert, V.P. of Clinical Development, Cerimon Pharmaceuticals
Cerimon Pharmaceuticals
PPD
Not Provided
Cerimon Pharmaceuticals
January 2010

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