Skip to main content
OpenTrials
Completed

NCT Number: NCT00266669

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Raynaud's Disease Cardiovascular Diseases Connective Tissue Diseases Embolism and Thrombosis Livedoid Vasculopathy Peripheral Vascular Diseases Raynaud Disease Scleroderma, Diffuse Scleroderma, Systemic Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Thrombosis Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

St. Joseph's Health Care, London, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topical organogel with nitroglycerin

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

MediQuest Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2005
Study completion
2006
First posted
Dec 19, 2005
Registry last updated
Aug 8, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.