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

Primary Purpose

Raynaud's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Topical organogel with nitroglycerin
Sponsored by
MediQuest Therapeutics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Raynaud's Disease focused on measuring Raynaud's Phenomenon, Raynaud's Disease, Scleroderma, Raynaud's Disease Secondary to Scleroderma, Raynaud's Disease Secondary to Other Autoimmune Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Stanford Medical School
  • University of Colorado at Denver and Health Sciences Center
  • University of Connecticut
  • Georgetown University Medical Center
  • University of Chicago Center for Advanced Medicine
  • Johns Hopkins Bayview Medical Center
  • Boston University School of Medicine
  • Arthritis Education & Treatment Center, PLLC
  • University of Medicine and Dentistry of New Jersey
  • The Center for Rheumatology
  • SUNY Stony Brook
  • Duke University
  • Medical University of Ohio
  • Medical University of South Carolina
  • University of Texas Medical School at Houston
  • Virginia Mason Benaroya Research Institute
  • Medical College of Wisconsin
  • St. Joseph's Health Care
  • SMBD Jewish General Hospital

Outcomes

Primary Outcome Measures

Improvements in Raynaud's Assessment Score comparing active to placebo
Reduction of number of Raynaud's events
Decrease in duration of Raynaud's events
Decrease in symptoms associated with Raynaud's
Assess safety: frequency and severity of adverse events associated with the study drug

Secondary Outcome Measures

Improvement in patient's health using physician's Global Assessment and patient's Heath Assessment Questions
Reduction in emergence of digital ulcers for patients with scleroderma

Full Information

First Posted
December 15, 2005
Last Updated
August 6, 2007
Sponsor
MediQuest Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00266669
Brief Title
Phase III Study of Topical Gel for Treatment and Prevention of Raynaud's Phenomenon
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
MediQuest Therapeutics

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Topical organogel with nitroglycerin
Primary Outcome Measure Information:
Title
Improvements in Raynaud's Assessment Score comparing active to placebo
Title
Reduction of number of Raynaud's events
Title
Decrease in duration of Raynaud's events
Title
Decrease in symptoms associated with Raynaud's
Title
Assess safety: frequency and severity of adverse events associated with the study drug
Secondary Outcome Measure Information:
Title
Improvement in patient's health using physician's Global Assessment and patient's Heath Assessment Questions
Title
Reduction in emergence of digital ulcers for patients with scleroderma

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Stanford Medical School
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado at Denver and Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
University of Connecticut
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
University of Chicago Center for Advanced Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Arthritis Education & Treatment Center, PLLC
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
University of Medicine and Dentistry of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
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
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Medical University of Ohio
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 Medical School at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Virginia Mason Benaroya Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
St. Joseph's Health Care
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
SMBD Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada

12. IPD Sharing Statement

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

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