Status:
UNKNOWN
Phase II Dose-Ranging Study of OrthoDerm Patch for Patients With Tennis Elbow
Lead Sponsor:
Cure Therapeutics
Conditions:
Tendonitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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.
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 de...
Eligibility Criteria
Inclusion
- males \>18 yr and \< 70 yr
- BMI \< 38
- chronic lateral epicondylitis (symptomatic \> 3 mo)
- pain on provocation \>/- 4 on 11 point scale
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
End Date :
November 1 2007
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT00447928
Start Date
April 1 2007
End Date
November 1 2007
Last Update
March 15 2007
Active Locations (1)
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1
to Be Determined
Warsaw, Poland