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Lab Study of MQX-503 in Treatment of Raynaud's

NCT ID: NCT00253331

Last Updated: 2007-05-30

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/PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2005-09-30

Brief Summary

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The purpose of this study is to determine, in comparison to a placebo control, the response to two dosage strengths of a topical gel formulation of nitroglycerin, MQX-303, in the determination of finger blood flow and skin temperature in the fingers of patients with moderate to severe Raynaud's phenomenon, follwoing exposure to cold temperatures.

Blood flow is determined by scanning laser Doppler equipment and skin temperature is measured using attached thermistor probes. Following baseline measurements, the study gel is applied, the hand is placed in a cold chamber, and then blood flow and skin temperature are monitored for the next two hours.

Each patient will receive multiple doses on different days so that each can serve as his/her own control in interpreting the response.

Detailed Description

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Conditions

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Raynaud Disease Raynaud Disease Secondary to Scleroderma Raynaud Secondary to Other Autoimmune Disease

Keywords

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Raynaud's sclerderma systemic sclerosis autoimmune disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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topical organogel with nitroglycerin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* clinical diagnosis of Raynaud's phenomenon
* outpoatients
* agree to apply gel as per protocol
* willing to discontinue current vasodilator therapy
* agree to stop other investigational medication for Raynaud's
* negative pregnancy test is fertile females
* able to give written informed consent and comply with study requirements

Exclusion Criteria

* current use of ay nitrate medication or medications that interact with nitroglycerin
* patients with a known allergy to nitroglycerin or topical gel ingredients
* patients with a history of migraine headaches
* patients with unstable medical problems
* patients with cognitive or language difficulties
* patients with screening lab values more than 20% outside of normal
* patients with open lesions at site of application
* women of child-bearing potential who are unwilling to comply with contraceptive requirements.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 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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Laura K Hummers, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Carin Dugowson, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington Medical College

Locations

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Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Site Status

University of Washington Medical College

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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MQT 03-001

Identifier Type: -

Identifier Source: org_study_id