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Dose Response Study of a Topical Formulation of Nitroglycerin for the Treatment of Raynaud's Phenomenon

NCT ID: NCT00480753

Last Updated: 2007-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2007-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Raynaud's Disease

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Nitroglycerin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MediQuest Therapeutics

INDUSTRY

Sponsor Role lead

Principal Investigators

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Lee Shapiro, MD

Role: PRINCIPAL_INVESTIGATOR

The Center for Rheumatology

Locations

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The Center for Rheumatology

Albany, New York, United States

Site Status

Countries

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United States

Other Identifiers

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07-003

Identifier Type: -

Identifier Source: org_study_id