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
Overview
- Phase
- Phase 2
- Intervention
- Dexamethasone Iontophoretic Patch (low dose)
- Conditions
- Lateral Epicondylitis
- Sponsor
- Travanti Pharma Inc.
- Enrollment
- 216
- Primary Endpoint
- Pain severity assessed by VAS (Visual Analog Scale)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
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
Arms & Interventions
1
Dexamethasone Iontophoretic Patch (low dose)
Intervention: Dexamethasone Iontophoretic Patch (low dose)
2
Dexamethasone Iontophoretic Patch (high dose)
Intervention: Dexamethasone Iontophoretic Patch (high dose)
3
Dexamethasone Passive Patch
Intervention: Dexamethasone Passive Patch
4
Placebo Patch
Intervention: Placebo Patch
Outcomes
Primary Outcomes
Pain severity assessed by VAS (Visual Analog Scale)
Time Frame: baseline to completion/termination
Secondary Outcomes
- Safety(up to 13 days)