Tendonitis Clinical Trial
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
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.
Status | Not yet recruiting |
Enrollment | 164 |
Est. completion date | November 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Poland | to Be Determined | Warsaw |
Lead Sponsor | Collaborator |
---|---|
Cure Therapeutics |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pain-free grip strength | |||
Secondary | pain at rest | |||
Secondary | pain on provocation | |||
Secondary | function |
Status | Clinical Trial | Phase | |
---|---|---|---|
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