Phase II Dose-Ranging Study of OrthoDerm Patch for Patients With Tennis Elbow
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ClinicalTrials.gov Identifier: NCT00447928 |
Recruitment Status : Unknown
Verified March 2007 by Cure Therapeutics.
Recruitment status was: Not yet recruiting
First Posted : March 15, 2007
Last Update Posted : March 15, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tendonitis | Drug: OrthoDerm transdermal nitroglycerin patch | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 164 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
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 |
Study Start Date : | April 2007 |
Study Completion Date : | November 2007 |

- pain-free grip strength
- pain at rest
- pain on provocation
- function

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00447928
Contact: Ronald M Burch, MD, PhD | 212-586-2226 | Rburch@curetherapeutics.com | |
Contact: Robert Ang, MD | 212-586-2226 | Rang@curetherapeutics.com |
Poland | |
to Be Determined | |
Warsaw, Poland |
Study Chair: | Ronald M Burch, MD, PhD | Cure Therapeutics, Inc |
ClinicalTrials.gov Identifier: | NCT00447928 |
Other Study ID Numbers: |
Orthoderm-1-001-06 |
First Posted: | March 15, 2007 Key Record Dates |
Last Update Posted: | March 15, 2007 |
Last Verified: | March 2007 |
tendonitis nitroglycerin nitric oxide lateral epicondylitis |
Tendinopathy Muscular Diseases Musculoskeletal Diseases Wounds and Injuries |
Tendon Injuries Nitroglycerin Vasodilator Agents |