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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2007 by Cure Therapeutics.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Cure Therapeutics

ClinicalTrials.gov Identifier:

NCT00447928

First received: March 13, 2007

Last updated: NA

Last verified: March 2007

History: No changes posted

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 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Elbow Injuries and Disorders

Drug Information available for: Nitroglycerin

U.S. FDA Resources

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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	Not yet recruiting
Warsaw, Poland

Sponsors and Collaborators

Cure Therapeutics

Investigators


Study Chair:	Ronald M Burch, MD, PhD	Cure Therapeutics, Inc

More Information

No publications provided


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

Keywords provided by Cure Therapeutics:


tendonitis nitroglycerin nitric oxide lateral epicondylitis

Additional relevant MeSH terms:


Nitroglycerin Cardiovascular Agents Pharmacologic Actions Therapeutic Uses Vasodilator Agents

ClinicalTrials.gov processed this record on February 27, 2015

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