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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
Information provided by:
Cure Therapeutics Identifier:
First received: March 13, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
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.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00447928

Contact: Ronald M Burch, MD, PhD 212-586-2226
Contact: Robert Ang, MD 212-586-2226

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00447928     History of Changes
Other Study ID Numbers: Orthoderm-1-001-06
Study First Received: March 13, 2007
Last Updated: March 13, 2007

Keywords provided by Cure Therapeutics:
nitric oxide
lateral epicondylitis

Additional relevant MeSH terms:
Tennis Elbow
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Arm Injuries
Vasodilator Agents processed this record on September 19, 2017