NCT00266669

Brief Summary

The purpose of this study is to investigate the efficacy and safety of a topical gel formulation of nitroglycerin, in comparison to a matching placebo, for patients with moderate to severe primary Raynaud's phenomenon or patients with Raynaud's phenomenon secondary to autoimmune diseases, such as scleroderma.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2005

Shorter than P25 for phase_3

Geographic Reach
2 countries

19 active sites

Status
completed

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

Study Start

First participant enrolled

December 1, 2005

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

August 8, 2007

Status Verified

August 1, 2007

First QC Date

December 15, 2005

Last Update Submit

August 6, 2007

Conditions

Raynaud's Disease

Keywords

Raynaud's PhenomenonRaynaud's DiseaseSclerodermaRaynaud's Disease Secondary to SclerodermaRaynaud's Disease Secondary to Other Autoimmune Disease

Outcome Measures

Primary Outcomes (5)

  • Improvements in Raynaud's Assessment Score comparing active to placebo

  • Reduction of number of Raynaud's events

  • Decrease in duration of Raynaud's events

  • Decrease in symptoms associated with Raynaud's

  • Assess safety: frequency and severity of adverse events associated with the study drug

Secondary Outcomes (2)

  • Improvement in patient's health using physician's Global Assessment and patient's Heath Assessment Questions

  • Reduction in emergence of digital ulcers for patients with scleroderma

Interventions

Topical organogel with nitroglycerinDRUG

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of Raynaud's phenomenon
  • or more Raynaud's events on a typical winter day
  • Agree to discontinue current treatments for Raynaud's
  • Negative pregnancy test and agree to use effective contraception during study

You may not qualify if:

  • Current use of nitrate medications or medications known to interact with nitroglycerin
  • Patients who currently use medications, like calcium channel blockers, that might interfere with study medication
  • Patients with a known allergy to nitroglycerin or common topical ingredients
  • Patients with a history of migraine headaches
  • Patients with a history of unstable medical problems
  • Patients with cognitive or language difficulties that would impair completion of assessment instruments
  • Patients with lab screening values more than 20% outside normal range
  • Patients with non-epithelialized skin lesions, in the area where the gel is to be applied, at the time of screening
  • Pregnant or nursing women
  • Women of child-bearing potential who are unwilling to comply with the contraceptive requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Stanford Medical School

Stanford, California, 94305, United States

Location

University of Colorado at Denver and Health Sciences Center

Denver, Colorado, 80204, United States

Location

University of Connecticut

Farmington, Connecticut, 06030, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

University of Chicago Center for Advanced Medicine

Chicago, Illinois, 60637, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

Arthritis Education & Treatment Center, PLLC

Grand Rapids, Michigan, 49546, United States

Location

University of Medicine and Dentistry of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

The Center for Rheumatology

Albany, New York, 12206, United States

Location

SUNY Stony Brook

East Setauket, New York, 11733, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Medical University of Ohio

Toledo, Ohio, 43614, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Texas Medical School at Houston

Houston, Texas, 77030, United States

Location

Virginia Mason Benaroya Research Institute

Seattle, Washington, 98101, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

St. Joseph's Health Care

London, Ontario, N6A 4V2, Canada

Location

SMBD Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Raynaud DiseaseScleroderma, Diffuse

Interventions

Nitroglycerin

Condition Hierarchy (Ancestors)

Livedoid VasculopathyThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesScleroderma, SystemicConnective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitro CompoundsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 15, 2005

First Posted

December 19, 2005

Study Start

December 1, 2005

Study Completion

May 1, 2006

Last Updated

August 8, 2007

Record last verified: 2007-08

Locations

US(17)CA(2)