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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00266669
Other study ID # 05-002
Secondary ID MQX-503 In-Life
Status Completed
Phase Phase 3
First received December 15, 2005
Last updated August 6, 2007
Start date December 2005
Est. completion date May 2006

Study information

Verified date August 2007
Source MediQuest Therapeutics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date May 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Topical organogel with nitroglycerin


Locations

Country Name City State
Canada St. Joseph's Health Care London Ontario
Canada SMBD Jewish General Hospital Montreal Quebec
United States The Center for Rheumatology Albany New York
United States Johns Hopkins Bayview Medical Center Baltimore Maryland
United States Boston University School of Medicine Boston Massachusetts
United States Medical University of South Carolina Charleston South Carolina
United States University of Chicago Center for Advanced Medicine Chicago Illinois
United States University of Colorado at Denver and Health Sciences Center Denver Colorado
United States Duke University Durham North Carolina
United States SUNY Stony Brook East Setauket New York
United States University of Connecticut Farmington Connecticut
United States Arthritis Education & Treatment Center, PLLC Grand Rapids Michigan
United States University of Texas Medical School at Houston Houston Texas
United States Medical College of Wisconsin Milwaukee Wisconsin
United States University of Medicine and Dentistry of New Jersey New Brunswick New Jersey
United States Virginia Mason Benaroya Research Institute Seattle Washington
United States Stanford Medical School Stanford California
United States Medical University of Ohio Toledo Ohio
United States Georgetown University Medical Center Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
MediQuest Therapeutics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improvements in Raynaud's Assessment Score comparing active to placebo
Primary Reduction of number of Raynaud's events
Primary Decrease in duration of Raynaud's events
Primary Decrease in symptoms associated with Raynaud's
Primary Assess safety: frequency and severity of adverse events associated with the study drug
Secondary Improvement in patient's health using physician's Global Assessment and patient's Heath Assessment Questions
Secondary Reduction in emergence of digital ulcers for patients with scleroderma
See also
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Enrolling by invitation NCT02615964 - Nova Cold Hands Raynaud's Disorder, a Disease Which Results in Decreased Blood Flow to the Hands and Feet. N/A
Completed NCT01309802 - A Two-Part Study of BOTOX® Therapy for Ischemic Digits Phase 2
Completed NCT00480753 - Dose Response Study of a Topical Formulation of Nitroglycerin for the Treatment of Raynaud's Phenomenon Phase 2
Completed NCT02396238 - Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR) N/A
Completed NCT00351117 - St. John's Wort in the Treatment of Raynaud's Phenomenon Phase 3
Completed NCT00528242 - Safety, Tolerability, and Pharmacodynamic Profile of Oral 2101 in Secondary Raynaud's Disease Phase 2
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Active, not recruiting NCT00577304 - A Study of a Topical Form of Nitroglycerin and Placebo in the Treatment and Prevention of Raynaud's Phenomenon Phase 3
Completed NCT00419419 - Phase III Study of a Topical Gel Formulation for Treatment and Prevention of Raynaud's Phenomenon Phase 3
Completed NCT01090492 - PF-00489791 For The Treatment Of Raynaud's Phase 2