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Phase III Study of Topical Gel for Treatment and Prevention of Raynaud's Phenomenon

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00266669
Recruitment Status : Completed
First Posted : December 19, 2005
Last Update Posted : August 8, 2007
Information provided by:
MediQuest Therapeutics

Brief Summary:
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 or disease Intervention/treatment Phase
Raynaud's Disease Drug: Topical organogel with nitroglycerin Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : December 2005
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Improvements in Raynaud's Assessment Score comparing active to placebo
  2. Reduction of number of Raynaud's events
  3. Decrease in duration of Raynaud's events
  4. Decrease in symptoms associated with Raynaud's
  5. Assess safety: frequency and severity of adverse events associated with the study drug

Secondary Outcome Measures :
  1. Improvement in patient's health using physician's Global Assessment and patient's Heath Assessment Questions
  2. Reduction in emergence of digital ulcers for patients with scleroderma

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00266669

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Sponsors and Collaborators
MediQuest Therapeutics

Layout table for additonal information Identifier: NCT00266669     History of Changes
Other Study ID Numbers: 05-002
MQX-503 In-Life
First Posted: December 19, 2005    Key Record Dates
Last Update Posted: August 8, 2007
Last Verified: August 2007
Keywords provided by MediQuest Therapeutics:
Raynaud's Phenomenon
Raynaud's Disease
Raynaud's Disease Secondary to Scleroderma
Raynaud's Disease Secondary to Other Autoimmune Disease
Additional relevant MeSH terms:
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Raynaud Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Vasodilator Agents