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

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. Identifier: NCT00869180
Recruitment Status : Completed
First Posted : March 25, 2009
Last Update Posted : January 28, 2010
Information provided by:
Cerimon Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Pain Ankle Sprain Drug: Diclofenac Sodium Drug: Matching Placebo Patch Phase 3

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 219 participants
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 Ankle Sprain
Study Start Date : February 2009
Primary Completion Date : June 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Diclofenac Sodium Patch Drug: Diclofenac Sodium
Topical diclofenac patch applied once daily to area of pain
Placebo Comparator: Topical Placebo Patch Drug: Matching Placebo Patch
Matching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; applied once daily

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

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

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

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

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 identifier (NCT number): NCT00869180

United States, Texas
Austin, Texas, United States, 78704
Sponsors and Collaborators
Cerimon Pharmaceuticals

Responsible Party: Shaily J. Reichert, V.P. of Clinical Development, Cerimon Pharmaceuticals Identifier: NCT00869180     History of Changes
Other Study ID Numbers: DCF-004
First Posted: March 25, 2009    Key Record Dates
Last Update Posted: January 28, 2010
Last Verified: January 2010

Keywords provided by Cerimon Pharmaceuticals:
ankle sprain
acute pain
Acute Pain due to Mild to Moderate Ankle Sprain

Additional relevant MeSH terms:
Acute Pain
Sprains and Strains
Ankle Injuries
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Wounds and Injuries
Leg Injuries
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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