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NCT00266669

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

Completed Phase 3 Last updated 6 August 2007
What this trial tests

Phase 3 trial testing Topical organogel with nitroglycerin in Raynaud's Disease in 200 participants. Completed in 1 May 2006.

Timeline
1 December 2005
1 May 2006

Quick facts

Lead sponsorMediQuest Therapeutics
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingdouble
Primary purposetreatment
Enrollment200
Start date1 December 2005
Estimated completion1 May 2006
Sites19 locations across United States, Canada

Drugs / interventions tested

Conditions studied

Sponsor

MediQuest Therapeutics — full company profile →

Who can join

Adults 18 to 70, any sex, with Raynaud's Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Evaluation of test characteristics for outcome measures used in Raynaud's phenomenon clinical trials.
    Gladue H, Maranian P, Paulus HE, Khanna D. · · 2013 · cited 28× · PMID 22972592 · DOI 10.1002/acr.21858
  2. Vasodilators for primary Raynaud's phenomenon.
    Su KY, Sharma M, Kim HJ, Kaganov E, et al · · 2021 · cited 15× · PMID 33998674 · DOI 10.1002/14651858.cd006687.pub4

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Other recruiting trials for Raynaud's Disease

Currently open trials in the same condition.

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