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

This study has been completed.
Information provided by:
MediQuest Therapeutics Identifier:
First received: December 15, 2005
Last updated: August 6, 2007
Last verified: August 2007
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 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

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

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00266669

  Show 19 Study Locations
Sponsors and Collaborators
MediQuest Therapeutics
  More Information Identifier: NCT00266669     History of Changes
Other Study ID Numbers: 05-002
MQX-503 In-Life
Study First Received: December 15, 2005
Last Updated: August 6, 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:
Raynaud Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Vasodilator Agents processed this record on September 20, 2017