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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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00447928     History of Changes
Other Study ID Numbers: Orthoderm-1-001-06
Study First Received: March 13, 2007
Last Updated: March 13, 2007
Health Authority: United States: Food and Drug Administration

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
 Arm Injuries
Nitroglycerin
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013