Raynaud's DiseasePhase 3NCT00577304
A Study of a Topical Form of Nitroglycerin and Placebo in the Treatment and Prevention of Raynaud's Phenomenon
A Phase 3 study testing Nitroglycerin and Topical AmphiMatrix in people with Raynaud's Disease and Raynaud's Disease Secondary to Scleroderma, run by MediQuest Therapeutics at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Raynaud's Disease, Raynaud's Disease Secondary to Scleroderma, Raynaud's Disease Secondary to Other Autoimmune Disease
- What is being tested?
- Nitroglycerin and Topical AmphiMatrix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 17 sitesUnited States
- Study dates
- Dec 2007to Mar 2008
- 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
The Center for Rheumatology
Albany, New York, 12206
Johns Hopkins University
Baltimore, Maryland, 21224
Boston University
Boston, Massachusetts, 02118
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Chicago
Chicago, Illinois, 60637
University of Colorado Health Sciences Center
Denver, Colorado, 80045
University of Connecticut
Farmington, Connecticut, 06030
Arthritis Education and Treatment Center, PLLC
Grand Rapids, Michigan, 49546
University of Texas at Houston
Houston, Texas, 77030
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
University of Medicine and Dentistry of New Jersey
New Brunswick, New Jersey, 08093
Stanford University
Stanford, California, 94305
SUNY Stony Brook
Stony Brook, New York, 11794
University of Toledo
Toledo, Ohio, 43614
Georgetown University
Washington D.C., District of Columbia, 20007
Carolina Arthritis
Wilmington, North Carolina, 28401
About this study
Official title: A Study of a Topical Formulation of Nitroglycerin, MQX-503, and Matching Vehicle in the Treatment and Prevention of Raynaud's Phenomenon
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.
Read the 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.
- Conditions
- Raynaud's Disease, Raynaud's Disease Secondary to Scleroderma, Raynaud's Disease Secondary to Other Autoimmune Disease
- Being tested
- Nitroglycerin, Topical AmphiMatrix
- Keywords
- Raynaud's, Nitroglycerin, Scleroderma
- 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.
NitroglycerinDrug
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.
Topical AmphiMatrixDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Other | Placebo - Topical AmphiMatrix Receives: Drug: Topical AmphiMatrix |
| 1 | Active comparator | Topical AmphiMatrix with Nitroglycerin Receives: Drug: Nitroglycerin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Raynaud's Condition Score
Measured: three months
Secondary outcomes (1)
Frequency and severity of adverse events.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionMar 2008 (estimated)
- Study completionMar 2008 (estimated)
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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MediQuest Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jan Ohrstrom, PhD, Study director, MediQuest Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00577304
- Sponsor's protocol ID
- 07-005
- Status last verified
- Apr 2008
- First submitted
- 18 Dec 2007
- Last updated
- 5 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of a Topical Formulation of Nitroglycerin, MQX-503, and Matching Vehicle in the Treatment and Prevention of Raynaud's Phenomenon
- ClinicalTrials.gov ID
- NCT00577304
- Acronym / sponsor ID
- 07-005
- Conditions
- Raynaud's Disease, Raynaud's Disease Secondary to Scleroderma, Raynaud's Disease Secondary to Other Autoimmune Disease
- Keywords
- Raynaud's, Nitroglycerin, Scleroderma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- MediQuest TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Mar 2008 (estimated)
- Study completion
- Mar 2008 (estimated)
- First posted
- 20 Dec 2007 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Other | Drug: Topical AmphiMatrixPlacebo - Topical AmphiMatrix |
| 1 | Active comparator | Drug: NitroglycerinTopical AmphiMatrix with Nitroglycerin |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| NitroglycerinIndividual 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. | Drug | 1 |
| Topical AmphiMatrixIndividual 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. | Drug | 2 |
Primary outcome
Reduction in Raynaud's Condition Score
Time frame: three months
1 secondary outcome
Frequency and severity of adverse events.
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2010.
- Sponsor web siteLink provided by the sponsor.
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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.
Jan Ohrstrom, PhD study director
MediQuest Therapeutics
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nitroglycerin and Topical AmphiMatrix in people with Raynaud's Disease and Raynaud's Disease Secondary to Scleroderma, run by MediQuest Therapeutics at 17 sites in United States.
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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 5 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. 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?
Results are not available in the source record.
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?
Reduction in Raynaud's Condition Score (time frame: three months). 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 5 Feb 2010.