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

MediQuest Therapeutics

Status and phase

Completed

Phase 3

Conditions

Raynaud's Disease

Treatments

Drug: Topical organogel with nitroglycerin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00266669

05-002

MQX-503 In-Life

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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