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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.
Information provided by:
Cerimon Pharmaceuticals Identifier:
First received: March 24, 2009
Last updated: January 26, 2010
Last verified: January 2010
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 Intervention Phase
Acute Pain Ankle Sprain Drug: Diclofenac Sodium 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 Ankle Sprain

Resource links provided by NLM:

Further study details as provided by Cerimon Pharmaceuticals:

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

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

Enrollment: 219
Study Start Date: February 2009
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00869180

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

Responsible Party: Shaily J. Reichert, V.P. of Clinical Development, Cerimon Pharmaceuticals Identifier: NCT00869180     History of Changes
Other Study ID Numbers: DCF-004
Study First Received: March 24, 2009
Last Updated: January 26, 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 processed this record on August 18, 2017