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Phase II Dose-Ranging Study of OrthoDerm Patch for Patients With Tennis Elbow
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2007 by Cure Therapeutics.
Recruitment status was: Not yet recruiting
Recruitment status was: Not yet recruiting
Sponsor:
Cure Therapeutics
Information provided by:
Cure Therapeutics
ClinicalTrials.gov Identifier:
NCT00447928
First received: March 13, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Tendonitis | Drug: OrthoDerm transdermal nitroglycerin patch | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Elbow Injuries and Disorders
Drug Information available for:
Nitroglycerin
U.S. FDA Resources
Further study details as provided by Cure Therapeutics:
Primary Outcome Measures:
- pain-free grip strength
Secondary Outcome Measures:
- pain at rest
- pain on provocation
- function
| Estimated Enrollment: | 164 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | November 2007 |
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00447928
Please refer to this study by its ClinicalTrials.gov identifier: NCT00447928
Contacts
| Contact: Ronald M Burch, MD, PhD | 212-586-2226 | Rburch@curetherapeutics.com | |
| Contact: Robert Ang, MD | 212-586-2226 | Rang@curetherapeutics.com |
Locations
| Poland | |
| to Be Determined | Not yet recruiting |
| Warsaw, Poland | |
Sponsors and Collaborators
Cure Therapeutics
Investigators
| Study Chair: | Ronald M Burch, MD, PhD | Cure Therapeutics, Inc |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00447928 History of Changes |
| Other Study ID Numbers: |
Orthoderm-1-001-06 |
| Study First Received: | March 13, 2007 |
| Last Updated: | March 13, 2007 |
Keywords provided by Cure Therapeutics:
|
tendonitis nitroglycerin nitric oxide lateral epicondylitis |
Additional relevant MeSH terms:
|
Tendinopathy Tennis Elbow Muscular Diseases Musculoskeletal Diseases Tendon Injuries |
Wounds and Injuries Arm Injuries Nitroglycerin Vasodilator Agents |
ClinicalTrials.gov processed this record on June 26, 2017