Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain

Phase 2

Terminated

• Conditions: Ankle Sprain
• Interventions: Drug: Matching placebo patch; Drug: diclofenac sodium

• Registration Number: NCT00640705
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-03-18
• Study First Submitted QC: 2008-03-18
• Study First Posted: 2008-03-21
• Primary Completion: 2008-07
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-03
• Last Update Posted: 2008-09-04
• Study Completion: 2008-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 170

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Matching placebo patch	Topical patch identical in appearance to active comparator, except without diclofenac sodium
A	diclofenac sodium	Topical diclofenac sodium patch

Primary Outcome Measures

Name	Time	Method
Assess the efficacy of diclofenac in subjects with mild to moderate ankle sprain.	7 days

Secondary Outcome Measures

Name	Time	Method
Assess the safety and tolerability of diclofenac in subjects with mild to moderate ankle sprain.	7 days

Trial Locations

Locations (1)

PPD; 🇺🇸 Austin, Texas, United States