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

Lateral Epicondylitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00794976
• Other study ID #: 1779
• Status: Completed
• Phase: Phase 2
• First received: November 20, 2008
• Last updated: May 11, 2015
• Start date: October 2008
• Est. completion date: May 2009

Study information

• Verified date: May 2015
• Source: Travanti Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• (Tennis Elbow)
• Lateral Epicondylitis
• Tennis Elbow

Intervention

Drug:
• Dexamethasone Iontophoretic Patch (low dose)

• Dexamethasone Iontophoretic Patch (high dose)

• Dexamethasone Passive Patch

• Placebo Patch

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Travanti Pharma Inc.	ResearchPoint

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain severity assessed by VAS (Visual Analog Scale)		baseline to completion/termination	No
Secondary	Safety		up to 13 days	Yes