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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-05-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Lateral Epicondylitis (Tennis Elbow)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Dexamethasone Iontophoretic Patch (low dose)

Group Type EXPERIMENTAL

Dexamethasone Iontophoretic Patch (low dose)

Intervention Type DRUG

2

Dexamethasone Iontophoretic Patch (high dose)

Group Type EXPERIMENTAL

Dexamethasone Iontophoretic Patch (high dose)

Intervention Type DRUG

3

Dexamethasone Passive Patch

Group Type EXPERIMENTAL

Dexamethasone Passive Patch

Intervention Type DRUG

4

Placebo Patch

Group Type PLACEBO_COMPARATOR

Placebo Patch

Intervention Type DRUG

Interventions

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Dexamethasone Iontophoretic Patch (low dose)

Intervention Type DRUG

Dexamethasone Iontophoretic Patch (high dose)

Intervention Type DRUG

Dexamethasone Passive Patch

Intervention Type DRUG

Placebo Patch

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No