NCT00447928

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
164

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2007

Completed
17 days until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

March 15, 2007

Status Verified

March 1, 2007

First QC Date

March 13, 2007

Last Update Submit

March 13, 2007

Conditions

Tendonitis

Keywords

tendonitisnitroglycerinnitric oxidelateral epicondylitis

Outcome Measures

Primary Outcomes (1)

  • pain-free grip strength

Secondary Outcomes (3)

  • pain at rest

  • pain on provocation

  • function

Interventions

OrthoDerm transdermal nitroglycerin patchDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • males \>18 yr and \< 70 yr
  • BMI \< 38
  • chronic lateral epicondylitis (symptomatic \> 3 mo)
  • pain on provocation \>/- 4 on 11 point scale

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

to Be Determined

Warsaw, Poland

Location

Related Publications (1)

  • 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.

    PMID: 18971247DERIVED

MeSH Terms

Conditions

TendinopathyTennis Elbow

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and InjuriesElbow TendinopathyElbow InjuriesArm Injuries

Study Officials

  • Ronald M Burch, MD, PhD

    Cure Therapeutics, Inc

    STUDY CHAIR

Central Study Contacts

Ronald M Burch, MD, PhD

CONTACT

212-586-2226Rburch@curetherapeutics.com

Robert Ang, MD

CONTACT

212-586-2226Rang@curetherapeutics.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 13, 2007

First Posted

March 15, 2007

Study Start

April 1, 2007

Study Completion

November 1, 2007

Last Updated

March 15, 2007

Record last verified: 2007-03

Locations

PL(1)