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Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain

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ClinicalTrials.gov Identifier: NCT00640705
Recruitment Status : Terminated (Sponsor decision)
First Posted : March 21, 2008
Last Update Posted : September 4, 2008
Sponsor:
Collaborator:
PPD
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 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 or disease Intervention/treatment Phase
Ankle Sprain Drug: diclofenac sodium Drug: Matching placebo patch Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
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.
Study Start Date : January 2008
Primary Completion Date : July 2008
Estimated Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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

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


Information from the National Library of Medicine

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

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

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 ClinicalTrials.gov identifier (NCT number): NCT00640705


Locations
United States, Texas
PPD
Austin, Texas, United States, 78744
Sponsors and Collaborators
Cerimon Pharmaceuticals
PPD
Investigators
Study Director: Dan Levitt, MD Cerimon Pharmaceuticals

Responsible Party: Dan Levitt, MD, Cerimon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00640705     History of Changes
Other Study ID Numbers: DCF-002
First Posted: March 21, 2008    Key Record Dates
Last Update Posted: September 4, 2008
Last Verified: September 2008

Additional relevant MeSH terms:
Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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