Raynaud's DiseasePhase 3NCT00419419
Phase III Study of a Topical Gel Formulation for Treatment and Prevention of Raynaud's Phenomenon
A Phase 3 study testing Topical AmphiMatrix with nitroglycerin (MQX-503) in people with Raynaud's Disease and Scleroderma, run by MediQuest Therapeutics at 12 sites in 3 countries.
Trial summary
The purpose of this research study is to test the safety, tolerability, and effectiveness of Topical AmphiMatrix with Nitroglycerin (MQX-503) to relieve Raynaud's symptoms and increase blood flow to the fingers. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Raynaud's Disease, Scleroderma, Autoimmune Diseases
- What is being tested?
- Topical AmphiMatrix with nitroglycerin (MQX-503)
- How many people
- 80 participants
- Where
- 12 sitesin 3 countries
- Study dates
- Dec 2006to not given
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Outpatients, 18 years to 70 years.
- Patients with a clinical diagnosis of Raynaud's phenomenon.
- Patients who are willing to discontinue current vasodilator therapies.
- Patients who agree not to use any other investigational medications or approved therapies to treat Raynaud's phenomenon and its symptoms while participating in this study.
- Negative pregnancy test in fertile women.
- Patients who are able to give written informed consent and comply with all study requirements.
Who cannot join
- Patients who concurrently use any nitrate medication or medications known to interact with Nitroglycerin.
- Patients who concurrently use any medication or device which might interfere with the study medication.
- Patients who have a known allergy to Nitroglycerin or common topical gel ingredients.
- Patients with a history of headaches.
- Patients who have a history of an unstable medical problem.
- Patients with cognitive or language difficulties.
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- Patients who, within the past three months, have had either a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension, or uncontrolled hypertension.
- Patients who participated in a study of any investigational drug within four weeks prior to Visit 1.
- Patients who have screening laboratory values which are 20% or greater of the upper or lower limit of normal.
- Patients who have had major surgery within six months of Visit 1.
- Patients with interfering skin conditions.
- Pregnant or nursing women.
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United States6 sites
The Center for Rheumatology
Albany, New York, 12206
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Duke University
Durham, North Carolina, 27710
University of Connecticut
Farmington, Connecticut, 06030
Standford Medical School
Stanford, California, 94305
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
United Kingdom5 sites
Royal National Hospital for Rheumatic Diseases
Bath, LX1 3EX
Ninewells Hospital and Medical School
Dundee, DD1 9SY
University of Leeds
Leeds, LS7 4SA
Royal Free Hospital
London, NW3 2QH
Hope Hospital
Salford, M6 8HD
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 research study is to test the safety, tolerability, and effectiveness of Topical AmphiMatrix with Nitroglycerin (MQX-503) 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 Topical AmphiMatrix formulation with 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 and with Raynaud's phenomenon secondary to autoimmune diseases such as scleroderma.
- Conditions
- Raynaud's Disease, Scleroderma, Autoimmune Diseases
- Being tested
- Topical AmphiMatrix with nitroglycerin (MQX-503)
- Keywords
- Raynaud's
- Medical subject headings
- Raynaud Disease, Scleroderma, Diffuse, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical AmphiMatrix with nitroglycerin (MQX-503)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Raynaud's Condition Score
Secondary outcomes (1)
Frequency and Severity of adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2007 (estimated)
- Study startDec 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
- Crossover
- Masking
- Double blind
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- MediQuest Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00419419
- Sponsor's protocol ID
- 06-005
- Status last verified
- May 2007
- First submitted
- 4 Jan 2007
- Last updated
- 30 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 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
- NCT00419419
- Acronym / sponsor ID
- 06-005
- Conditions
- Raynaud's Disease, Scleroderma, Autoimmune Diseases
- Keywords
- Raynaud's
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- MediQuest TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- First posted
- 8 Jan 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 (MQX-503) 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 Topical AmphiMatrix formulation with 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 and with Raynaud's phenomenon secondary to autoimmune diseases such as scleroderma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Outpatients, 18 years to 70 years.
- Patients with a clinical diagnosis of Raynaud's phenomenon.
- Patients who are willing to discontinue current vasodilator therapies.
- Patients who agree not to use any other investigational medications or approved therapies to treat Raynaud's phenomenon and its symptoms while participating in this study.
- Negative pregnancy test in fertile women.
Key exclusion criteria (12 listed)
- Patients who concurrently use any nitrate medication or medications known to interact with Nitroglycerin.
- Patients who concurrently use any medication or device which might interfere with the study medication.
- Patients who have a known allergy to Nitroglycerin or common topical gel ingredients.
- Patients with a history of headaches.
- Patients who have a history of an unstable medical problem.
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 AmphiMatrix with nitroglycerin (MQX-503) | Drug | – |
Primary outcome
Reduction in Raynaud's Condition Score
1 secondary outcome
Frequency and Severity of adverse events
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 30 May 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.
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Topical AmphiMatrix with nitroglycerin (MQX-503) in people with Raynaud's Disease and Scleroderma, run by MediQuest Therapeutics at 12 sites in 3 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 6 inclusion and 12 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 30 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, United Kingdom, Sweden. 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?
Reduction in Raynaud's Condition Score. 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 30 May 2007.