Phase II Dose-Ranging Study of OrthoDerm Patch for Patients With Tennis Elbow - Full Text View

Sponsored by:	Cure Therapeutics
Information provided by:	Cure Therapeutics
ClinicalTrials.gov Identifier:	NCT00447928

Purpose

The purpose of the study is to evaluate the effectiveness and safety of the use of low-dose nitroglycerin transdermal patches to treat pain and function in chronic tennis elbow.

Condition	Intervention	Phase
Tendonitis	Drug: OrthoDerm transdermal nitroglycerin patch	Phase II

MedlinePlus related topics: Elbow Injuries and Disorders

Drug Information available for: Nitroglycerin Nitric oxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Phase II Dose-Ranging Study of the OrthoDerm Transdermal Nitroglycerin Patch for Patients With Chronic Lateral Epicondylitis

Further study details as provided by Cure Therapeutics:

Primary Outcome Measures:

pain-free grip strength

Secondary Outcome Measures:

pain at rest
pain on provocation
function

Estimated Enrollment:	164
Study Start Date:	April 2007
Estimated Study Completion Date:	November 2007

Detailed Description:

Chronic tendonitis remains difficult to treat. Nitric oxide has been demonstrated to stimulate tenocytes to proliferate, differentiate and produce matrix components including collagen. Studies have demonstrated that nitroglycerin transdermal patches, which release nitric oxide, reduce pain and increase function in patients with chronic tendonitis. The purpose of the present study is to examine the efficacy of three dose levels of nitroglycerin, compared to placebo, in reducing pain and increasing function in patients with chronic (greater than three months' duration) lateral epicondylitis.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

males >18 yr and < 70 yr
BMI < 38
chronic lateral epicondylitis (symptomatic > 3 mo)
pain on provocation >/- 4 on 11 point scale

Exclusion Criteria:

patients on other pain medications
bilateral elbow pain
any humerus elbow or forearm fracture or surgery
signs of injury other than lateral epicondylitis
any concomitant disease or pain of the upper extremity
orthostatic hypotension
patients taking MAO inhibitors, phosphodiesterase inhibitors, adrenergic agents
pregnant or nursing women

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447928

Contacts

Contact: Ronald M Burch, MD, PhD	212-586-2226	Rburch@curetherapeutics.com
Contact: Robert Ang, MD	212-586-2226	Rang@curetherapeutics.com

Locations

Poland
to Be Determined
Warsaw, Poland

Sponsors and Collaborators

Cure Therapeutics

Investigators

Study Chair:

Ronald M Burch, MD, PhD

Cure Therapeutics, Inc

More Information

Study ID Numbers:	Orthoderm-1-001-06
Study First Received:	March 13, 2007
Last Updated:	March 13, 2007
ClinicalTrials.gov Identifier:	NCT00447928
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cure Therapeutics:

tendonitis
nitroglycerin
nitric oxide
lateral epicondylitis

Study placed in the following topic categories:

Nitroglycerin
Nitric Oxide
Tendinopathy
Tendon Injuries
Muscular Diseases

Musculoskeletal Diseases
Tennis Elbow
Wounds and Injuries
Disorders of Environmental Origin
Arm Injuries

Additional relevant MeSH terms:

Vasodilator Agents
Therapeutic Uses
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009