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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00447928
Other study ID # Orthoderm-1-001-06
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received March 13, 2007
Last updated March 13, 2007
Start date April 2007
Est. completion date November 2007

Study information

Verified date March 2007
Source Cure Therapeutics
Contact Ronald M Burch, MD, PhD
Phone 212-586-2226
Email Rburch@curetherapeutics.com
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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 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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
OrthoDerm transdermal nitroglycerin patch


Locations

Country Name City State
Poland to Be Determined Warsaw

Sponsors (1)

Lead Sponsor Collaborator
Cure Therapeutics

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary pain-free grip strength
Secondary pain at rest
Secondary pain on provocation
Secondary function
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