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

This study has been completed.
Sponsor:
Information provided by:
MediQuest Therapeutics
ClinicalTrials.gov Identifier:
NCT00266669
First received: December 15, 2005
Last updated: August 6, 2007
Last verified: August 2007
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 19 Study Locations
Sponsors and Collaborators
MediQuest Therapeutics
  More Information

No publications provided

ClinicalTrials.gov 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
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

Additional relevant MeSH terms:
Raynaud Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Nitroglycerin
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014