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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00794976
Recruitment Status : Completed
First Posted : November 21, 2008
Last Update Posted : May 13, 2015
Sponsor:
Collaborator:
ResearchPoint
Information provided by (Responsible Party):
Travanti Pharma Inc.

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).

Condition or disease Intervention/treatment Phase
Lateral Epicondylitis (Tennis Elbow) Drug: Dexamethasone Iontophoretic Patch (low dose) Drug: Dexamethasone Iontophoretic Patch (high dose) Drug: Dexamethasone Passive Patch Drug: Placebo Patch Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : October 2008
Primary Completion Date : May 2009
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Dexamethasone Iontophoretic Patch (low dose)
Drug: Dexamethasone Iontophoretic Patch (low dose)
Experimental: 2
Dexamethasone Iontophoretic Patch (high dose)
Drug: Dexamethasone Iontophoretic Patch (high dose)
Experimental: 3
Dexamethasone Passive Patch
Drug: Dexamethasone Passive Patch
Placebo Comparator: 4
Placebo Patch
Drug: Placebo Patch



Primary Outcome Measures :
  1. Pain severity assessed by VAS (Visual Analog Scale) [ Time Frame: baseline to completion/termination ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: up to 13 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00794976


Locations
United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
Tucson, Arizona, United States
United States, California
San Diego, California, United States
United States, Colorado
Steamboat Springs, Colorado, United States
United States, Florida
Tampa, Florida, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, South Carolina
Columbia, South Carolina, United States
United States, Texas
Dallas, Texas, United States
United States, Virginia
Arlington, Virginia, United States
Sponsors and Collaborators
Travanti Pharma Inc.
ResearchPoint
Investigators
Study Director: Robert Arnold Travanti Pharma Inc.

Responsible Party: Travanti Pharma Inc.
ClinicalTrials.gov Identifier: NCT00794976     History of Changes
Other Study ID Numbers: 1779
First Posted: November 21, 2008    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action