Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain - Full Text View

Sponsors and Collaborators:	Cerimon Pharmaceuticals PPD
Information provided by:	Cerimon Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00640705

Purpose

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 II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess the safety and tolerability of diclofenac in subjects with mild to moderate ankle sprain. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

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
A: Active Comparator Topical diclofenac sodium patch	Drug: diclofenac sodium 15 mg (1%) topical patch; measuring 7 cm by 10 cm; applied once daily
B: Placebo Comparator 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

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

No publications provided

Responsible Party:	Cerimon Pharmaceuticals, Inc. ( Dan Levitt, MD )
Study ID Numbers:	DCF-002
Study First Received:	March 18, 2008
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00640705 History of Changes
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Study placed in the following topic categories:

Anti-Inflammatory Agents
Analgesics, Non-Narcotic
Cyclooxygenase Inhibitors
Wounds and Injuries
Diclofenac
Disorders of Environmental Origin

Anti-Inflammatory Agents, Non-Steroidal
Pain
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Sprains and Strains

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Wounds and Injuries
Disorders of Environmental Origin
Diclofenac
Enzyme Inhibitors
Pharmacologic Actions

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Sprains and Strains

ClinicalTrials.gov processed this record on September 10, 2009