Phase III Study of Topical Gel for Treatment and Prevention of Raynaud's Phenomenon - Full Text View

Sponsored by:	MediQuest Therapeutics
Information provided by:	MediQuest Therapeutics
ClinicalTrials.gov Identifier:	NCT00266669

Purpose

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.

Condition	Intervention	Phase
Raynaud's Disease	Drug: Topical organogel with nitroglycerin	Phase III

MedlinePlus related topics: Autoimmune Diseases Raynaud's Disease

Drug Information available for: Nitroglycerin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase III "in-Life" Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud's Phenomenon

Further study details as provided by MediQuest Therapeutics:

Primary Outcome Measures:

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 Outcome Measures:

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

Estimated Enrollment:	200
Study Start Date:	December 2005
Estimated Study Completion Date:	May 2006

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of Raynaud's phenomenon
2 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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00266669

Show 19 Study Locations

Sponsors and Collaborators

MediQuest Therapeutics

More Information

Study ID Numbers:	05-002, MQX-503 In-Life
Study First Received:	December 15, 2005
Last Updated:	August 6, 2007
ClinicalTrials.gov Identifier:	NCT00266669
Health Authority:	United States: Food and Drug Administration

Keywords provided by MediQuest Therapeutics:

Raynaud's Phenomenon
Raynaud's Disease
Scleroderma
Raynaud's Disease Secondary to Scleroderma
Raynaud's Disease Secondary to Other 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 16, 2009