Trial | NCT00794976  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    urea ...

  • Study Participants

    216
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 Started
Oct 31
2008
Primary Completion
May 31
2009
Study Completion
May 31
2009
Last Update
May 13
2015
Estimate

Drug Dexamethasone Iontophoretic Patch (low dose)

Drug Dexamethasone Iontophoretic Patch (high dose)

Drug Dexamethasone Passive Patch

Drug Placebo Patch

1 Experimental

Dexamethasone Iontophoretic Patch (low dose)

2 Experimental

Dexamethasone Iontophoretic Patch (high dose)

3 Experimental

Dexamethasone Passive Patch

4 Placebo Comparator

Placebo Patch

Criteria 

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
No Results Posted