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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 because the information has not been verified recently.
Verified March 2007 by Cure Therapeutics.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Cure Therapeutics
ClinicalTrials.gov Identifier:
NCT00447928
First received: March 13, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted

March 13, 2007
March 13, 2007
April 2007
Not Provided
pain-free grip strength
Same as current
No Changes Posted
  • pain at rest
  • pain on provocation
  • function
Same as current
Not Provided
Not Provided
 
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Tendonitis
Drug: OrthoDerm transdermal nitroglycerin patch
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
164
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
Both
18 Years to 70 Years
No
Contact: Ronald M Burch, MD, PhD 212-586-2226 Rburch@curetherapeutics.com
Contact: Robert Ang, MD 212-586-2226 Rang@curetherapeutics.com
Poland
 
NCT00447928
Orthoderm-1-001-06
No
Not Provided
Cure Therapeutics
Not Provided
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