Dexamethasone Iontophoretic Patch for the Treatment of Pain Associated With Lateral Epicondylitis - Full Text View

Sponsors and Collaborators:	Travanti Pharma Inc. ResearchPoint
Information provided by:	Travanti Pharma Inc.
ClinicalTrials.gov Identifier:	NCT00794976

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 II

MedlinePlus related topics: Elbow Injuries and Disorders

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Dexamethasone Iontophoretic Patch (low dose)
2: Experimental	Drug: Dexamethasone Iontophoretic Patch (high dose)
3: Experimental	Drug: Dexamethasone Passive Patch
4: Placebo Comparator	Drug: Placebo Patch

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

Contacts

Contact: Beth Meyer, ResearchPoint (CRO)	(512) 450-6198	bmeyer@researchpoint.com
Contact: Jennifer Migl, ResearchPoint (CRO)	(512) 450-6204	jmigl@researchpoint.com

Locations

United States, Alabama
	Recruiting
Birmingham, Alabama, United States
United States, Arizona
	Recruiting
Phoenix, Arizona, United States
	Recruiting
Tucson, Arizona, United States
United States, California
	Recruiting
San Diego, California, United States
United States, Colorado
	Recruiting
Steamboat Springs, Colorado, United States
United States, Florida
	Recruiting
Tampa, Florida, United States
United States, Oklahoma
	Recruiting
Oklahoma City, Oklahoma, United States
United States, South Carolina
	Recruiting
Columbia, South Carolina, United States
United States, Texas
	Recruiting
Dallas, Texas, United States
United States, Virginia
	Recruiting
Arlington, Virginia, United States

Sponsors and Collaborators

Travanti Pharma Inc.

ResearchPoint

Investigators

Study Director:

Robert Arnold

Travanti Pharma Inc.

More Information

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

Study placed in the following topic categories:

Dexamethasone
Musculoskeletal Diseases
Tennis Elbow
Wounds and Injuries

Disorders of Environmental Origin
Pain
Dexamethasone acetate
Arm Injuries

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics

Glucocorticoids
Hormones
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009