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

Tendonitis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00447928
• Other study ID #: Orthoderm-1-001-06
• Status: Not yet recruiting
• Phase: Phase 2
• First received: March 13, 2007
• Last updated: March 13, 2007
• Start date: April 2007
• Est. completion date: November 2007

Study information

• Verified date: March 2007
• Source: Cure Therapeutics
• Contact: Ronald M Burch, MD, PhD
• Phone: 212-586-2226
• Email: Rburch[@]curetherapeutics.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 164
• Est. completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Tendonitis
• Tennis Elbow

Intervention

Drug:
• OrthoDerm transdermal nitroglycerin patch

Locations

Country	Name	City	State
Poland	to Be Determined	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Cure Therapeutics

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain-free grip strength
Secondary	pain at rest
Secondary	pain on provocation
Secondary	function