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A Study of a Topical Form of Nitroglycerin and Placebo in the Treatment and Prevention of Raynaud's Phenomenon

Primary Purpose

Raynaud's Disease, Raynaud's Disease Secondary to Scleroderma, Raynaud's Disease Secondary to Other Autoimmune Disease

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Nitroglycerin
Topical AmphiMatrix
Sponsored by
MediQuest Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Raynaud's Disease focused on measuring Raynaud's, Nitroglycerin, Scleroderma

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Outpatients ages 15 - 70.
  • Patients with a diagnosis of Raynaud's phenomenon.
  • Patients who agree to apply study medication to their fingers.
  • Patients who are willing to stop current topical vasodilator therapies.
  • Patients who agree not to start or change dosage of current oral vasodilator therapies.
  • Patients who agree not to use any nitrate therapy while participating in this study.
  • Negative pregnancy test in fertile women and agreement to use effective contraception throughout the study.

Exclusion Criteria:

  • Patients who currently use nitrate medication or medications known to interact with nitroglycerin.
  • Patients who have an allergy to nitroglycerin or common topical gel ingredients.
  • Patients with a history of severe headaches.
  • Patients with an unstable medical problem.
  • Patients with cognitive or language difficulties that would impair their ability to complete assessment of pain instruments.
  • Patients who have had a recent heart attack or other uncontrolled heart condition.
  • Patients who have participated in an investigational drug study within four weeks of visit one.
  • Patients who have clinically significant abnormal lab values.
  • Patients who have had recent major abdominal, thoracic or vascular surgery.
  • Patients with interfering skin conditions.
  • Pregnant or nursing women or women unwilling to comply with contraceptive requirements.

Sites / Locations

  • Stanford University
  • University of Colorado Health Sciences Center
  • University of Connecticut
  • Georgetown University
  • University of Chicago
  • Johns Hopkins University
  • Boston University
  • Arthritis Education and Treatment Center, PLLC
  • University of Minnesota
  • University of Medicine and Dentistry of New Jersey
  • The Center for Rheumatology
  • SUNY Stony Brook
  • Carolina Arthritis
  • University of Toledo
  • Medical University of South Carolina
  • University of Texas at Houston
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

2

1

Arm Description

Placebo - Topical AmphiMatrix

Topical AmphiMatrix with Nitroglycerin

Outcomes

Primary Outcome Measures

Reduction in Raynaud's Condition Score

Secondary Outcome Measures

Frequency and severity of adverse events.

Full Information

First Posted
December 18, 2007
Last Updated
February 3, 2010
Sponsor
MediQuest Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00577304
Brief Title
A Study of a Topical Form of Nitroglycerin and Placebo in the Treatment and Prevention of Raynaud's Phenomenon
Official Title
A Study of a Topical Formulation of Nitroglycerin, MQX-503, and Matching Vehicle in the Treatment and Prevention of Raynaud's Phenomenon
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Unknown status
Study Start Date
December 2007 (undefined)
Primary Completion Date
March 2008 (Anticipated)
Study Completion Date
March 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
MediQuest Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
The purpose of this clinical study is to determine, in a controlled fashion, the ability of a topical formulation of Nitroglycerin, MQX-503, to improve the patient's health assessment as indicated by patient and physician assessments, decrease the frequency of Raynaud's events, decrease the duration of Raynaud's events, and decrease the symptoms (pain, tingling, numbness) in the fingers of Raynaud's patients. The study will include patients with moderate to severe primary Raynaud's Phenomenon (RP) and with moderate to severe Raynaud's Phenomenon secondary to autoimmune diseases, such as scleroderma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Raynaud's Disease, Raynaud's Disease Secondary to Scleroderma, Raynaud's Disease Secondary to Other Autoimmune Disease
Keywords
Raynaud's, Nitroglycerin, Scleroderma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Other
Arm Description
Placebo - Topical AmphiMatrix
Arm Title
1
Arm Type
Active Comparator
Arm Description
Topical AmphiMatrix with Nitroglycerin
Intervention Type
Drug
Intervention Name(s)
Nitroglycerin
Intervention Description
Individual pouch applicators containing 0.5 grams of Topical AmphiMatrix with Nitroglycerin. Each dose contains 4.5mg of Nitroglycerin. Each dose is intended for topical usage on both hands up to five minutes before an anticipated Raynaud's attack or up to 5 minutes after the beginning of an actual Raynaud's attack. Limited to four applications per day; minimum of two hours between applications.
Intervention Type
Drug
Intervention Name(s)
Topical AmphiMatrix
Intervention Description
Individual pouch applicators containing 0.5 grams of Topical AmphiMatrix. Each dose is intended for topical usage on both hands up to five minutes before an anticipated Raynaud's attack or up to 5 minutes after the beginning of an actual Raynaud's attack. Limited to four applications per day; minimum of two hours between applications.
Primary Outcome Measure Information:
Title
Reduction in Raynaud's Condition Score
Time Frame
three months
Secondary Outcome Measure Information:
Title
Frequency and severity of adverse events.
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Outpatients ages 15 - 70. Patients with a diagnosis of Raynaud's phenomenon. Patients who agree to apply study medication to their fingers. Patients who are willing to stop current topical vasodilator therapies. Patients who agree not to start or change dosage of current oral vasodilator therapies. Patients who agree not to use any nitrate therapy while participating in this study. Negative pregnancy test in fertile women and agreement to use effective contraception throughout the study. Exclusion Criteria: Patients who currently use nitrate medication or medications known to interact with nitroglycerin. Patients who have an allergy to nitroglycerin or common topical gel ingredients. Patients with a history of severe headaches. Patients with an unstable medical problem. Patients with cognitive or language difficulties that would impair their ability to complete assessment of pain instruments. Patients who have had a recent heart attack or other uncontrolled heart condition. Patients who have participated in an investigational drug study within four weeks of visit one. Patients who have clinically significant abnormal lab values. Patients who have had recent major abdominal, thoracic or vascular surgery. Patients with interfering skin conditions. Pregnant or nursing women or women unwilling to comply with contraceptive requirements.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Ohrstrom, PhD
Organizational Affiliation
MediQuest Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Connecticut
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Arthritis Education and Treatment Center, PLLC
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
University of Medicine and Dentistry of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08093
Country
United States
Facility Name
The Center for Rheumatology
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
SUNY Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Carolina Arthritis
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
University of Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University of Texas at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mqti.com
Description
Sponsor web site

Learn more about this trial

A Study of a Topical Form of Nitroglycerin and Placebo in the Treatment and Prevention of Raynaud's Phenomenon

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