NCT00447928

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

A Randomized, Double-Blind, Placebo-Controlled Phase II Dose-Ranging Study of the OrthoDerm Transdermal Nitroglycerin Patch for Patients With Chronic Lateral Epicondylitis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 164 (planned)
• Sponsor: Cure Therapeutics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Tendonitis

Interventions

Type	Name	Description
DRUG	OrthoDerm transdermal nitroglycerin patch

Timeline

• Start date: 2007-04-01
• Completion: 2007-11-01
• First posted: 2007-03-15
• Last updated: 2007-03-15

Locations

1 site across 1 country: Poland