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| 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 |
| 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 |
| Estimated Enrollment: | 164 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | November 2007 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Ronald M Burch, MD, PhD | 212-586-2226 | Rburch@curetherapeutics.com |
| Contact: Robert Ang, MD | 212-586-2226 | Rang@curetherapeutics.com |
| Poland | |||||
| to Be Determined | |||||
| Warsaw, Poland | |||||
| Cure Therapeutics |
| Study Chair: | Ronald M Burch, MD, PhD | Cure Therapeutics, Inc |
More Information
| Study ID Numbers: | Orthoderm-1-001-06 |
| First Received: | March 13, 2007 |
| Last Updated: | March 13, 2007 |
| ClinicalTrials.gov Identifier: | NCT00447928 |
| Health Authority: | United States: Food and Drug Administration |
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