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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2007 by Cure Therapeutics.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00447928
First Posted: March 15, 2007
Last Update Posted: March 15, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Cure Therapeutics
  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 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Cure Therapeutics:

Primary Outcome Measures:
  • pain-free grip strength

Secondary Outcome Measures:
  • pain at rest
  • pain on provocation
  • function

Estimated Enrollment: 164
Study Start Date: April 2007
Estimated Study Completion Date: November 2007
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00447928


Contacts
Contact: Ronald M Burch, MD, PhD 212-586-2226 Rburch@curetherapeutics.com
Contact: Robert Ang, MD 212-586-2226 Rang@curetherapeutics.com

Locations
Poland
to Be Determined Not yet recruiting
Warsaw, Poland
Sponsors and Collaborators
Cure Therapeutics
Investigators
Study Chair: Ronald M Burch, MD, PhD Cure Therapeutics, Inc
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00447928     History of Changes
Other Study ID Numbers: Orthoderm-1-001-06
First Submitted: March 13, 2007
First Posted: March 15, 2007
Last Update Posted: March 15, 2007
Last Verified: March 2007

Keywords provided by Cure Therapeutics:
tendonitis
nitroglycerin
nitric oxide
lateral epicondylitis

Additional relevant MeSH terms:
Tendinopathy
Tennis Elbow
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Elbow Tendinopathy
Arm Injuries
Nitroglycerin
Vasodilator Agents