NCT00480753

Brief Summary

The purpose of this clinical study is to determine the response to two different dosage strengths of a topical nitroglycerin gel in patients with Raynaud's Phenomenon. Patient fingers will be monitored for changes in blood flow and skin temperature. Symptoms of pain, tingling and numbness will also be monitored.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 31, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

December 24, 2007

Status Verified

December 1, 2007

First QC Date

May 29, 2007

Last Update Submit

December 18, 2007

Conditions

Raynaud's Disease

Keywords

Raynaud's phenomenonRaynaud's DiseaseRaynaud's disease secondary to sclerodermaRaynaud's phenomenon secondary to autoimmune disease

Outcome Measures

Primary Outcomes (1)

  • Changes in blood flow in the fingers of the non-dominant hand after the induction of constriction of blood vessels by exposure to local cold temperatures.

    130 minutes

Secondary Outcomes (2)

  • Reduction in skin temperature recovery time and symptoms in the fingers of the non-dominant hand after the induction of constriction of blood vessels by exposure to local cold temperatures.

    130 minutes

  • Frequency and severity of adverse events

    2 weeks

Interventions

NitroglycerinDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Raynaud's phenomenon
  • Patients who are willing to discontinue any current therapies for Raynaud's phenomenon

You may not qualify if:

  • The use of any medication containing nitroglycerin or known to interact with nitroglycerin
  • Patients with a history of migraine or other severe headaches
  • Open skin lesions or skin conditions in the area where medication is to be applied
  • Pregnant or nursing women or those wishing to become pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Center for Rheumatology

Albany, New York, 12206, United States

Location

MeSH Terms

Conditions

Raynaud Disease

Interventions

Nitroglycerin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitro CompoundsOrganic Chemicals

Study Officials

  • Lee Shapiro, MD

    The Center for Rheumatology

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 29, 2007

First Posted

May 31, 2007

Study Start

May 1, 2007

Study Completion

August 1, 2007

Last Updated

December 24, 2007

Record last verified: 2007-12

Locations

US(1)