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

This study has been completed.
Sponsor:
Collaborator:
ResearchPoint
Information provided by:
Travanti Pharma Inc.
ClinicalTrials.gov Identifier:
NCT00794976
First received: November 20, 2008
Last updated: May 19, 2009
Last verified: May 2009
History of Changes
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Travanti Pharma Inc.:

Primary Outcome Measures:
  • Pain severity assessed by VAS (Visual Analog Scale) [ Time Frame: baseline to completion/termination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: up to 13 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: October 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Dexamethasone Iontophoretic Patch (low dose)
Experimental: 2 Drug: Dexamethasone Iontophoretic Patch (high dose)
Experimental: 3 Drug: Dexamethasone Passive Patch
Placebo Comparator: 4 Drug: Placebo Patch

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

Responsible Party: Vice President of Marketing, Sales, and Business Development, Travanti Pharma Inc.
ClinicalTrials.gov Identifier: NCT00794976     History of Changes
Other Study ID Numbers: 1779
Study First Received: November 20, 2008
Last Updated: May 19, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tennis Elbow
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013