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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
Cure Therapeutics

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Enrollment : 164 participants
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 : April 2007
Study Completion Date : November 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. pain-free grip strength

Secondary Outcome Measures :
  1. pain at rest
  2. pain on provocation
  3. function

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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
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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
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Contact: Ronald M Burch, MD, PhD 212-586-2226 Rburch@curetherapeutics.com
Contact: Robert Ang, MD 212-586-2226 Rang@curetherapeutics.com

Locations
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Poland
to Be Determined
Warsaw, Poland
Sponsors and Collaborators
Cure Therapeutics
Investigators
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Study Chair: Ronald M Burch, MD, PhD Cure Therapeutics, Inc
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00447928    
Other Study ID Numbers: Orthoderm-1-001-06
First Posted: March 15, 2007    Key Record Dates
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:
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Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Wounds and Injuries
 Tendon Injuries
Nitroglycerin
Vasodilator Agents