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Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain

This study has been terminated.
(Sponsor decision)
Information provided by:
Cerimon Pharmaceuticals Identifier:
First received: March 18, 2008
Last updated: September 3, 2008
Last verified: September 2008

The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium patch to the skin near or over the painful area. In this study, the location being studied will be either the left or right ankle.

The secondary purpose of this study is to assess the safety and tolerability of a diclofenac patch on the skin.

Condition Intervention Phase
Ankle Sprain Drug: diclofenac sodium Drug: Matching placebo patch Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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 Pain Due to Mild to Moderate Ankle Sprain.

Resource links provided by NLM:

Further study details as provided by Cerimon Pharmaceuticals:

Primary Outcome Measures:
  • Assess the efficacy of diclofenac in subjects with mild to moderate ankle sprain. [ Time Frame: 7 days ]

Secondary Outcome Measures:
  • Assess the safety and tolerability of diclofenac in subjects with mild to moderate ankle sprain. [ Time Frame: 7 days ]

Enrollment: 170
Study Start Date: January 2008
Estimated Study Completion Date: October 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Topical diclofenac sodium patch
Drug: diclofenac sodium
15 mg (1%) topical patch; measuring 7 cm by 10 cm; applied once daily
Other Name: diclofenac
Placebo Comparator: B
Topical patch identical in appearance to active comparator, except without diclofenac sodium
Drug: Matching placebo patch
Matching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; measuring 7 cm by 10 cm; applied once daily
Other Name: placebo comparator

Detailed Description:
Cerimon Pharmaceuticals is investigating a topical patch formulation of diclofenac sodium containing 15 mg of diclofenac sodium for the local treatment of acute musculoskeletal pain.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 to 75 years of age
  • Has sustained a painful Grade 1 or 2 ankle sprain (Appendix H) no more than 48 hours prior to study entry
  • Presence of pain of at least 5, with a maximum of 9, on an 11-point Numerical Rating Scale (NRS)

Exclusion Criteria:

  • Grade 3 ankle sprain or bilateral sprain (see Appendix H)
  • Previous injury to the same ankle within 3 months prior to current injury
  • Aspirin or short half-life NSAID use within 12 hours, or longer half-life NSAID use within 24 hours prior to study entry (Appendix B)
  • Opioid use within 24 hours prior to study entry
  • Topical treatment, other than ice packs, applied to the painful region since time of injury
  • A history of peptic ulcer disease within 1 year of study entry, any history of gastrointestinal bleeding or coagulation disorder
  • A history of, or evidence for, underlying disease in the injured ankle, such as osteoarthritis or gout
  • Clinically significant, poorly controlled pulmonary, gastrointestinal, hepatic, renal, endocrine, or cardiovascular disease
  • A history of hypersensitivity to diclofenac or diclofenac-containing products
  • A history of intolerance to acetaminophen (rescue medication in this trial)
  • A history of skin sensitivity to adhesives (e.g. adhesive tape)
  • Pregnant or breastfeeding women and women of child-bearing potential not using effective means of contraception
  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: NCT00640705

United States, Texas
Austin, Texas, United States, 78744
Sponsors and Collaborators
Cerimon Pharmaceuticals
Study Director: Dan Levitt, MD Cerimon Pharmaceuticals
  More Information

Responsible Party: Dan Levitt, MD, Cerimon Pharmaceuticals, Inc. Identifier: NCT00640705     History of Changes
Other Study ID Numbers: DCF-002
Study First Received: March 18, 2008
Last Updated: September 3, 2008

Additional relevant MeSH terms:
Sprains and Strains
Ankle Injuries
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 September 21, 2017