Dose Response Study of a Topical Formulation of Nitroglycerin for the Treatment of Raynaud's Phenomenon - Full Text View

Sponsored by:	MediQuest Therapeutics
Information provided by:	MediQuest Therapeutics
ClinicalTrials.gov Identifier:	NCT00480753

Purpose

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.

Condition	Intervention	Phase
Raynaud's Disease	Drug: Nitroglycerin	Phase II

MedlinePlus related topics: Raynaud's Disease

Drug Information available for: Nitroglycerin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Crossover Assignment, Efficacy Study
Official Title:	Phase II Dose Response Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, in the Treatment of Raynaud's Phenomenon

Further study details as provided by MediQuest Therapeutics:

Primary Outcome Measures:

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. [ Time Frame: 130 minutes ]

Secondary Outcome Measures:

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. [ Time Frame: 130 minutes ]
Frequency and severity of adverse events [ Time Frame: 2 weeks ]

Estimated Enrollment:	15
Study Start Date:	May 2007
Study Completion Date:	August 2007

Detailed Description:

It is the intention of this protocol to study, in a controlled manner, the response of fingers of patients with Raynaud's phenomenon to two dosage strengths of a fast acting topical formulation of Nitroglycerin, MQX-503. Patients may have moderate to severe primary Raynaud's phenomenon or Raynaud's phenomenon secondary to autoimmune diseases such as scleroderma.

Quantitative changes in blood flow in the fingers of the non-dominant hand will be measured after the clinical induction of constriction of blood vessels by exposure to local cold temperatures. Secondarily, the quantitative reduction in skin temperature recovery time and symptoms of pain, tingling and numbness associated with Raynaud's phenomenon will be evaluated using a patient hand symptom analog assessment score. The frequency and severity of adverse events associated with MQX-503 will be assessed.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480753

Locations

United States, New York
The Center for Rheumatology
Albany, New York, United States, 12206

Sponsors and Collaborators

MediQuest Therapeutics

Investigators

Principal Investigator:

Lee Shapiro, MD

The Center for Rheumatology

More Information

Study ID Numbers:	07-003
Study First Received:	May 29, 2007
Last Updated:	December 18, 2007
ClinicalTrials.gov Identifier:	NCT00480753
Health Authority:	United States: Food and Drug Administration

Keywords provided by MediQuest Therapeutics:

Raynaud's phenomenon
Raynaud's Disease
Raynaud's disease secondary to scleroderma
Raynaud's phenomenon secondary to autoimmune disease

Study placed in the following topic categories:

Nitroglycerin
Peripheral Vascular Diseases
Autoimmune Diseases

Raynaud Disease
Vascular Diseases
Neoplasm Metastasis

Additional relevant MeSH terms:

Vasodilator Agents
Therapeutic Uses
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009