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

• Status: Unknown status
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cure Therapeutics
• Treatments: Nitroglycerin

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