Skip to main content
OpenTrials
Completed

NCT Number: NCT00794976

Dexamethasone Iontophoretic 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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lateral Epicondylitis (Tennis Elbow) Arm Injuries Elbow Injuries Elbow Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Injuries Tennis Elbow Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Birmingham, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for 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

Treatment and study plan

Dexamethasone Iontophoretic Patch (low dose)

Drug

Dexamethasone Iontophoretic Patch (high dose)

Drug

Dexamethasone Passive Patch

Drug

Placebo Patch

Drug

Primary outcomes

  1. Pain severity assessed by VAS (Visual Analog Scale)

    Time frame: baseline to completion/termination

Secondary outcomes

  1. Safety

    Time frame: up to 13 days

Sponsors and collaborators

Lead sponsor

Travanti Pharma Inc.

Industry

Collaborators

  • ResearchPoint

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 21, 2008
Registry last updated
May 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.