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

Travanti Pharma

Status and phase: Completed; Phase 2

Conditions: (Tennis Elbow); Lateral Epicondylitis

Treatments: Drug: Placebo Patch; Drug: Dexamethasone Passive Patch; Drug: Dexamethasone Iontophoretic Patch (high dose); Drug: Dexamethasone Iontophoretic Patch (low dose)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00794976

1779

Details and patient eligibility

About

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).

Full 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.

Enrollment: 216 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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216 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

Dexamethasone Iontophoretic Patch (low dose)

Treatment:

Drug: Dexamethasone Iontophoretic Patch (low dose)

2

Experimental group

Description:

Dexamethasone Iontophoretic Patch (high dose)

Treatment:

Drug: Dexamethasone Iontophoretic Patch (high dose)

3

Experimental group

Description:

Dexamethasone Passive Patch

Treatment:

Drug: Dexamethasone Passive Patch

4

Placebo Comparator group

Description:

Placebo Patch

Treatment:

Drug: Placebo Patch