Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain
Information source: Cerimon Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ankle Sprain
Intervention: diclofenac sodium (Drug); Matching placebo patch (Drug)
Phase: Phase 2/Phase 3
Status: Active, not recruiting
Sponsored by: Cerimon Pharmaceuticals Official(s) and/or principal investigator(s):
Dan Levitt, MD, Study Director, Affiliation: Cerimon Pharmaceuticals
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Assess the efficacy of diclofenac in subjects with mild to moderate ankle sprain.
Secondary outcome: Assess the safety and tolerability of diclofenac in subjects with mild to moderate ankle sprain.
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
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
PPD, Austin, Texas 78744, United States
Additional Information
Starting date: January 2008
Ending date: August 2008
Last updated: June 19, 2008
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