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

Information source: Cure Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tendonitis

Intervention: OrthoDerm transdermal nitroglycerin patch (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: Cure Therapeutics

Official(s) and/or principal investigator(s):
Ronald M Burch, MD, PhD, Study Chair, Affiliation: Cure Therapeutics, Inc

Overall contact:
Ronald M Burch, MD, PhD, Phone: 212-586-2226, Email: Rburch@curetherapeutics.com


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.

Clinical Details

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

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

Primary outcome: pain-free grip strength

Secondary outcome:

pain at rest

pain on provocation


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.


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


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

Locations and Contacts

Ronald M Burch, MD, PhD, Phone: 212-586-2226, Email: Rburch@curetherapeutics.com

to Be Determined, Warsaw, Poland; Not yet recruiting
Additional Information

Starting date: April 2007
Last updated: March 13, 2007

Page last updated: August 23, 2015

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