Dexamethasone Iontophoretic Patch for the Treatment of Pain Associated With Lateral Epicondylitis

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of a Dexamethasone Iontophoretic Transdermal Patch for the Treatment of Pain Associated With Lateral Epicondylitis

The objective of this study is to determine the safety and efficacy of a dexamethasone iontophoretic transdermal patch for the treatment of pain associated with lateral epicondylitis (tennis elbow).

Detailed Description:

This trial is a randomized, double-blind, placebo-controlled, parallel-group trial in subjects diagnosed with lateral epicondylitis (tennis elbow). Subjects entered into the trial will be assigned to one of four treatment groups. The total duration is up to 13 days of trial participation.

Inclusion Criteria:

• Subjects with onset of lateral epicondylitis symptoms no more than 12 weeks prior to study entry
• Female patients of childbearing potential must agree to use a medically accepted form of birth control.

Exclusion Criteria:

• Subjects with other medical conditions/injuries of the elbow that would account for pain in the area
• Subjects who would require continuation of current pain medications during treatment
• Must not have received a prior corticosteroid injection for lateral epicondylitis in the affected arm