Raynaud's DiseasePhase 3NCT00266669
Phase III Study of Topical Gel for Treatment and Prevention of Raynaud's Phenomenon
A Phase 3 study testing Topical organogel with nitroglycerin in people with Raynaud's Disease, run by MediQuest Therapeutics at 19 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Raynaud's Disease
- What is being tested?
- Topical organogel with nitroglycerin
- How many people
- 200 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Dec 2005to May 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States17 sites
The Center for Rheumatology
Albany, New York, 12206
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Boston University School of Medicine
Boston, Massachusetts, 02118
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Chicago Center for Advanced Medicine
Chicago, Illinois, 60637
University of Colorado at Denver and Health Sciences Center
Denver, Colorado, 80204
Duke University
Durham, North Carolina, 27710
SUNY Stony Brook
East Setauket, New York, 11733
University of Connecticut
Farmington, Connecticut, 06030
Arthritis Education & Treatment Center, PLLC
Grand Rapids, Michigan, 49546
University of Texas Medical School at Houston
Houston, Texas, 77030
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Medicine and Dentistry of New Jersey
New Brunswick, New Jersey, 08903
Virginia Mason Benaroya Research Institute
Seattle, Washington, 98101
Stanford Medical School
Stanford, California, 94305
Medical University of Ohio
Toledo, Ohio, 43614
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Canada2 sites
St. Joseph's Health Care
London, Ontario, N6A 4V2
SMBD Jewish General Hospital
Montreal, Quebec, H3T 1E2
About this study
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
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.
- Conditions
- Raynaud's Disease
- Being tested
- Topical organogel with nitroglycerin
- Keywords
- Raynaud's Phenomenon, Raynaud's Disease, Scleroderma, Raynaud's Disease Secondary to Scleroderma, Raynaud's Disease Secondary to Other Autoimmune Disease
- Medical subject headings
- Raynaud Disease, Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical organogel with nitroglycerinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (2)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2005 (estimated)
- Study startDec 2005
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Raynaud's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- MediQuest Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00266669
- Sponsor's protocol ID
- 05-002
- Other IDs
- MQX-503 In-Life
- Status last verified
- Aug 2007
- First submitted
- 15 Dec 2005
- Last updated
- 8 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00266669
- Acronym / sponsor ID
- 05-002
- Conditions
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- MediQuest TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Study completion
- May 2006
- First posted
- 19 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical organogel with nitroglycerin | Drug | – |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Topical organogel with nitroglycerin in people with Raynaud's Disease, run by MediQuest Therapeutics at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvements in Raynaud's Assessment Score comparing active to placebo. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2007.