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
1 other identifier
interventional
216
1 country
10
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2008
Shorter than P25 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 20, 2008
CompletedFirst Posted
Study publicly available on registry
November 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedMay 13, 2015
May 1, 2015
7 months
November 20, 2008
May 11, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Pain severity assessed by VAS (Visual Analog Scale)
baseline to completion/termination
Secondary Outcomes (1)
Safety
up to 13 days
Study Arms (4)
1
EXPERIMENTALDexamethasone Iontophoretic Patch (low dose)
2
EXPERIMENTALDexamethasone Iontophoretic Patch (high dose)
3
EXPERIMENTALDexamethasone Passive Patch
4
PLACEBO COMPARATORPlacebo Patch
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Travanti Pharma Inc.lead
- ResearchPointcollaborator
Study Sites (10)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Steamboat Springs, Colorado, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Columbia, South Carolina, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Arlington, Virginia, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robert Arnold
Travanti Pharma Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2008
First Posted
November 21, 2008
Study Start
October 1, 2008
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
May 13, 2015
Record last verified: 2015-05