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

• Sponsor: Cure Therapeutics (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT00447928
• Collaborator: (none)
• Enrollment: 164
• Location: 1
• Duration (Months): 7
• Patients Per Site Per Month: 23.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Tendonitis	Drug: OrthoDerm transdermal nitroglycerin patch	Phase 2

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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• 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
• Study Start Date: Apr 1, 2007
• Study Completion Date: Nov 1, 2007

Outcome Measures

Primary Outcome Measures

1. pain-free grip strength []

Secondary Outcome Measures

1. pain at rest []

2. pain on provocation []

3. function []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	to Be Determined	Warsaw		Poland

Sponsors and Collaborators

• Cure Therapeutics

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00447928
• Other Study ID Numbers: Orthoderm-1-001-06
• First Posted: Mar 15, 2007
• Last Update Posted: Mar 15, 2007
• Last Verified: Mar 1, 2007

• Keywords provided by , ,: tendonitis; nitroglycerin; nitric oxide; lateral epicondylitis
• Additional relevant MeSH terms: Tendinopathy; Nitroglycerin

Study Results

No Results Posted as of Mar 15, 2007