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Vasodilator
A Study of a Topical Form of Nitroglycerin and Placebo in the Treatment and Prevention of Raynaud's Phenomenon
Phase 3
Waitlist Available
Research Sponsored by MediQuest Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group
All Individual Drugs Already Approved
Summary
The purpose of this research study is to test the safety, tolerability, and effectiveness of Topical AmphiMatrix with Nitroglycerin (MQX0503) to relieve Raynaud's symptoms and increase blood flow to the fingers.
Eligible Conditions
- Scleroderma
- Raynaud's phenomenon
- Raynaud's Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: 2Experimental Treatment1 Intervention
Placebo - Topical AmphiMatrix
Group II: 1Active Control1 Intervention
Topical AmphiMatrix with Nitroglycerin
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Who is running the clinical trial?
MediQuest TherapeuticsLead Sponsor
10 Previous Clinical Trials
622 Total Patients Enrolled
Jan Ohrstrom, PhDStudy DirectorMediQuest Therapeutics