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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00794976

Enrollment

216

Registered

2008-11-21

Start date

2008-10-31

Completion date

2009-05-31

Last updated

2015-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lateral Epicondylitis, (Tennis Elbow)

Brief summary

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

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.

Interventions

DRUGDexamethasone Iontophoretic Patch (low dose)

DRUGDexamethasone Iontophoretic Patch (high dose)

DRUGDexamethasone Passive Patch

DRUGPlacebo Patch

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Pain severity assessed by VAS (Visual Analog Scale)	baseline to completion/termination

Secondary

Measure	Time frame
Safety	up to 13 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026