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

A Randomized, Double-Blind, Placebo-Controlled Phase II Dose-Ranging Study of the OrthoDerm Transdermal Nitroglycerin Patch for Patients With Chronic Lateral Epicondylitis

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00447928
Enrollment
164
Registered
2007-03-15
Start date
2007-04-30
Completion date
2007-11-30
Last updated
2007-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tendonitis

Keywords

tendonitis, nitroglycerin, nitric oxide, lateral epicondylitis

Brief 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.

Detailed 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.

Interventions

DRUGOrthoDerm transdermal nitroglycerin patch

Sponsors

Cure Therapeutics
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frame
pain-free grip strength

Secondary

MeasureTime frame
pain at rest
pain on provocation
function

Countries

Poland

Contacts

Primary ContactRonald M Burch, MD, PhD
Rburch@curetherapeutics.com212-586-2226
Backup ContactRobert Ang, MD
Rang@curetherapeutics.com212-586-2226

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026