Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain

Ankle Sprain Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00640705
• Other study ID #: DCF-002
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: March 18, 2008
• Last updated: September 3, 2008
• Start date: January 2008
• Est. completion date: October 2008

Study information

• Verified date: September 2008
• Source: Cerimon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 170
• Est. completion date: October 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprain

Intervention

Drug:
• diclofenac sodium
15 mg (1%) topical patch; measuring 7 cm by 10 cm; applied once daily
• 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

Locations

Country	Name	City	State
United States	PPD	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Cerimon Pharmaceuticals	PPD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the efficacy of diclofenac in subjects with mild to moderate ankle sprain.		7 days	No
Secondary	Assess the safety and tolerability of diclofenac in subjects with mild to moderate ankle sprain.		7 days	No