Phase II Dose-Ranging Study of OrthoDerm Patch for Patients With Tennis Elbow
Information source: Cure Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tendonitis
Intervention: OrthoDerm transdermal nitroglycerin patch (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: Cure Therapeutics Official(s) and/or principal investigator(s):
Ronald M Burch, MD, PhD, Study Chair, Affiliation: Cure Therapeutics, Inc
Overall contact:
Ronald M Burch, MD, PhD, Phone: 212-586-2226, Email: Rburch@curetherapeutics.com
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: pain-free grip strength
Secondary outcome: pain at restpain on provocation function
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
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Ronald M Burch, MD, PhD, Phone: 212-586-2226, Email: Rburch@curetherapeutics.com
to Be Determined, Warsaw, Poland; Not yet recruiting
Additional Information
Starting date: April 2007
Last updated: March 13, 2007
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