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

May 11, 2015 updated by: Travanti Pharma Inc.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
      • Tucson, Arizona, United States
    • California
      • San Diego, California, United States
    • Colorado
      • Steamboat Springs, Colorado, United States
    • Florida
      • Tampa, Florida, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • South Carolina
      • Columbia, South Carolina, United States
    • Texas
      • Dallas, Texas, United States
    • Virginia
      • Arlington, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Dexamethasone Iontophoretic Patch (low dose)
Drug: Dexamethasone Iontophoretic Patch (low dose)
Experimental: 2
Dexamethasone Iontophoretic Patch (high dose)
Drug: Dexamethasone Iontophoretic Patch (high dose)
Experimental: 3
Dexamethasone Passive Patch
Drug: Dexamethasone Passive Patch
Placebo Comparator: 4
Placebo Patch
Drug: Placebo Patch

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety
Time Frame: up to 13 days
up to 13 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Travanti Pharma Inc.

Collaborators

ResearchPoint

Investigators

  • Study Director: Robert Arnold, Travanti Pharma Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

November 20, 2008

First Submitted That Met QC Criteria

November 20, 2008

First Posted (Estimate)

November 21, 2008

Study Record Updates

Last Update Posted (Estimate)

May 13, 2015

Last Update Submitted That Met QC Criteria

May 11, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1779

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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