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

Travanti Pharma Inc.216 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

216

Conditions

Lateral Epicondylitis (Tennis Elbow)

Interventions

Dexamethasone Iontophoretic Patch (low dose)DRUG

Dexamethasone Iontophoretic Patch (high dose)DRUG

Dexamethasone Passive PatchDRUG

Placebo Patch

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Phoenix, Arizona, United States

Unnamed facility

Tucson, Arizona, United States

Unnamed facility

San Diego, California, United States

Outcomes

Primary Outcomes

Pain severity assessed by VAS (Visual Analog Scale)

Time frame: baseline to completion/termination

Secondary Outcomes

Safety

Time frame: up to 13 days

Data from ClinicalTrials.gov

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