NCT00419419

Brief Summary

The purpose of this research study is to test the safety, tolerability, and effectiveness of Topical AmphiMatrix with Nitroglycerin (MQX-503) to relieve Raynaud's symptoms and increase blood flow to the fingers.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Geographic Reach
3 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 8, 2007

Completed
Last Updated

May 30, 2007

Status Verified

May 1, 2007

First QC Date

January 4, 2007

Last Update Submit

May 29, 2007

Conditions

Raynaud's DiseaseSclerodermaAutoimmune Diseases

Keywords

Raynaud's

Outcome Measures

Primary Outcomes (1)

  • Reduction in Raynaud's Condition Score

Secondary Outcomes (1)

  • Frequency and Severity of adverse events

Interventions

Topical AmphiMatrix with nitroglycerin (MQX-503)DRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Outpatients, 18 years to 70 years.
  • Patients with a clinical diagnosis of Raynaud's phenomenon.
  • Patients who are willing to discontinue current vasodilator therapies.
  • Patients who agree not to use any other investigational medications or approved therapies to treat Raynaud's phenomenon and its symptoms while participating in this study.
  • Negative pregnancy test in fertile women.
  • Patients who are able to give written informed consent and comply with all study requirements.

You may not qualify if:

  • Patients who concurrently use any nitrate medication or medications known to interact with Nitroglycerin.
  • Patients who concurrently use any medication or device which might interfere with the study medication.
  • Patients who have a known allergy to Nitroglycerin or common topical gel ingredients.
  • Patients with a history of headaches.
  • Patients who have a history of an unstable medical problem.
  • Patients with cognitive or language difficulties.
  • Patients who, within the past three months, have had either a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension, or uncontrolled hypertension.
  • Patients who participated in a study of any investigational drug within four weeks prior to Visit 1.
  • Patients who have screening laboratory values which are 20% or greater of the upper or lower limit of normal.
  • Patients who have had major surgery within six months of Visit 1.
  • Patients with interfering skin conditions.
  • Pregnant or nursing women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Standford Medical School

Stanford, California, 94305, United States

Location

University of Connecticut

Farmington, Connecticut, 06030, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

The Center for Rheumatology

Albany, New York, 12206, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Lund University Hospital

Lund, 221 185, Sweden

Location

Royal National Hospital for Rheumatic Diseases

Bath, LX1 3EX, United Kingdom

Location

Ninewells Hospital and Medical School

Dundee, DD1 9SY, United Kingdom

Location

University of Leeds

Leeds, LS7 4SA, United Kingdom

Location

Royal Free Hospital

London, NW3 2QH, United Kingdom

Location

Hope Hospital

Salford, M6 8HD, United Kingdom

Location

MeSH Terms

Conditions

Raynaud DiseaseScleroderma, DiffuseAutoimmune Diseases

Interventions

Nitroglycerin

Condition Hierarchy (Ancestors)

Livedoid VasculopathyThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesScleroderma, SystemicConnective Tissue DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Nitro CompoundsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 4, 2007

First Posted

January 8, 2007

Study Start

December 1, 2006

Last Updated

May 30, 2007

Record last verified: 2007-05

Locations

US(6)SE(1)GB(5)