Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain

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.

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.

Study Overview

• Status: Terminated
• Conditions: Ankle Sprain
• Intervention / Treatment: Drug: diclofenac sodium; Drug: Matching placebo patch

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
• Enrollment (Actual): 170
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • PPD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assess the efficacy of diclofenac in subjects with mild to moderate ankle sprain.	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Assess the safety and tolerability of diclofenac in subjects with mild to moderate ankle sprain.	7 days

Collaborators and Investigators

• Sponsor: Cerimon Pharmaceuticals
• Collaborators: PPD
• Investigators: Study Director: Dan Levitt, MD, Cerimon Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): July 1, 2008
• Study Completion (Anticipated): October 1, 2008

Study Registration Dates

• First Submitted: March 18, 2008
• First Submitted That Met QC Criteria: March 18, 2008
• First Posted (Estimate): March 21, 2008

Study Record Updates

• Last Update Posted (Estimate): September 4, 2008
• Last Update Submitted That Met QC Criteria: September 3, 2008
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Sprains and Strains; Ankle Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: DCF-002