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

Primary Purpose

Tendonitis

Status

Unknown status

Phase

Phase 2

Locations

Poland

Study Type

Interventional

Intervention

OrthoDerm transdermal nitroglycerin patch

About this trial

This is an interventional treatment trial for Tendonitis focused on measuring tendonitis, nitroglycerin, nitric oxide, lateral epicondylitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

to Be Determined

Outcomes

Primary Outcome Measures

pain-free grip strength

Secondary Outcome Measures

pain at rest

pain on provocation

function

Full Information

NCT ID

NCT00447928

First Posted

March 13, 2007

Last Updated

March 13, 2007

Sponsor

Cure Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT00447928

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

March 2007

Overall Recruitment Status

Unknown status

Study Start Date

April 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Cure Therapeutics

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tendonitis

Keywords

tendonitis, nitroglycerin, nitric oxide, lateral epicondylitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

164 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

OrthoDerm transdermal nitroglycerin patch

Primary Outcome Measure Information:

Title

pain-free grip strength

Secondary Outcome Measure Information:

Title

pain at rest

Title

pain on provocation

Title

function

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ronald M Burch, MD, PhD

Phone

212-586-2226

Rburch@curetherapeutics.com

First Name & Middle Initial & Last Name or Official Title & Degree

Robert Ang, MD

Phone

212-586-2226

Rang@curetherapeutics.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronald M Burch, MD, PhD

Organizational Affiliation

Cure Therapeutics, Inc

Official's Role

Study Chair

Facility Information:

Facility Name

to Be Determined

City

Warsaw

Country

Poland

12. IPD Sharing Statement

Citations:

PubMed Identifier

18971247

Citation

Paoloni JA, Murrell GA, Burch RM, Ang RY. Randomised, double-blind, placebo-controlled clinical trial of a new topical glyceryl trinitrate patch for chronic lateral epicondylosis. Br J Sports Med. 2009 Apr;43(4):299-302. doi: 10.1136/bjsm.2008.053108. Epub 2008 Oct 29.

Results Reference

derived

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

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