CClinicalTrials.gg
Status unknownNCT00447928Updated Mar 15, 2007

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

A Phase 2 interventional study of OrthoDerm transdermal nitroglycerin patch in Tendonitis, sponsored by Cure Therapeutics. Status unknown at 1 site in Poland. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2007-03-15.

Sponsored by Cure Therapeutics · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2007), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
164
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Tendonitis

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Keywords

  • tendonitis
  • nitroglycerin
  • nitric oxide
  • lateral epicondylitis
03

In context

Tendinopathy

413 studies on the registry are indexed under Tendinopathy; 64 are open to participants now.

This study's enrollment of 164 is above the median of 50 across 339 interventional studies indexed under Tendinopathy.

Browse Tendinopathy studies →

Lead sponsor

This is the only study on the registry with Cure Therapeutics as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
164 participants

Interventions

  • DrugOrthoDerm transdermal nitroglycerin patch
06

What researchers measure

Primary outcomes

  1. pain-free grip strength

Secondary outcomes

  1. pain at rest

  2. pain on provocation

  3. function

07

Study locations

1 site
  • to Be Determined
    Warsaw, Poland
08

References and documents

Publications

  • 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. PubMed 18971247 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00447928
Lead sponsor
Cure Therapeutics
First posted
Mar 15, 2007
Start date
Apr 2007
Completion
Nov 2007
Last update
Mar 15, 2007

Study contacts

Ronald M Burch, MD, PhD
Contact
Rburch@curetherapeutics.com
212-586-2226
Robert Ang, MD
Contact
Rang@curetherapeutics.com
212-586-2226
Ronald M Burch, MD, PhD
study chair · Cure Therapeutics, Inc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.

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