Back to resultsDexamethasone Iontophoretic Patch for the Treatment of Pain Associated With Lateral Epicondylitis
Primary Purpose
Lateral Epicondylitis, (Tennis Elbow)
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone Iontophoretic Patch (low dose)
Dexamethasone Iontophoretic Patch (high dose)
Dexamethasone Passive Patch
Placebo Patch
Sponsored by
About this trial
This is an interventional treatment trial for Lateral Epicondylitis
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
4
Arm Description
Dexamethasone Iontophoretic Patch (low dose)
Dexamethasone Iontophoretic Patch (high dose)
Dexamethasone Passive Patch
Placebo Patch
Outcomes
Primary Outcome Measures
Pain severity assessed by VAS (Visual Analog Scale)
Secondary Outcome Measures
Safety
Full Information
NCT ID
NCT00794976
First Posted
November 20, 2008
Last Updated
May 11, 2015
Sponsor
Travanti Pharma Inc.
Collaborators
ResearchPoint
1. Study Identification
Unique Protocol Identification Number
NCT00794976
Brief Title
Dexamethasone Iontophoretic Patch for the Treatment of Pain Associated With Lateral Epicondylitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Travanti Pharma Inc.
Collaborators
ResearchPoint
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis, (Tennis Elbow)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
216 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Dexamethasone Iontophoretic Patch (low dose)
Arm Title
2
Arm Type
Experimental
Arm Description
Dexamethasone Iontophoretic Patch (high dose)
Arm Title
3
Arm Type
Experimental
Arm Description
Dexamethasone Passive Patch
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Placebo Patch
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Iontophoretic Patch (low dose)
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Iontophoretic Patch (high dose)
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Passive Patch
Intervention Type
Drug
Intervention Name(s)
Placebo Patch
Primary Outcome Measure Information:
Title
Pain severity assessed by VAS (Visual Analog Scale)
Time Frame
baseline to completion/termination
Secondary Outcome Measure Information:
Title
Safety
Time Frame
up to 13 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Arnold
Organizational Affiliation
Travanti Pharma Inc.
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Steamboat Springs
State/Province
Colorado
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Columbia
State/Province
South Carolina
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Arlington
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dexamethasone Iontophoretic Patch for the Treatment of Pain Associated With Lateral Epicondylitis
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