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

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. Identifier: NCT00447928
Recruitment Status : Unknown
Verified March 2007 by Cure Therapeutics.
Recruitment status was:  Not yet recruiting
First Posted : March 15, 2007
Last Update Posted : March 15, 2007
Information provided by:
Cure Therapeutics

March 13, 2007
March 15, 2007
March 15, 2007
April 2007
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pain-free grip strength
Same as current
No Changes Posted
  • pain at rest
  • pain on provocation
  • function
Same as current
Not Provided
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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
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.
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.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Drug: OrthoDerm transdermal nitroglycerin patch
Not Provided
Paoloni JA, Murrell GA, Burch RM, Ang RY. Randomised, double-blind, placebo-controlled clinical trial of a new topical glyceryl trinitrate patch for chronic lateral epicondylosis. Br J Sports Med. 2009 Apr;43(4):299-302. doi: 10.1136/bjsm.2008.053108. Epub 2008 Oct 29.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
November 2007
Not Provided

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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Cure Therapeutics
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Study Chair: Ronald M Burch, MD, PhD Cure Therapeutics, Inc
Cure Therapeutics
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP