Raynaud DiseasePhase 2/3NCT00253331
Lab Study of MQX-503 in Treatment of Raynaud's
A Phase 2/3 study testing topical organogel with nitroglycerin in people with Raynaud Disease and Raynaud Disease Secondary to Scleroderma, run by MediQuest Therapeutics at 2 sites in United States.
Trial summary
The purpose of this study is to determine, in comparison to a placebo control, the response to two dosage strengths of a topical gel formulation of nitroglycerin, MQX-303, in the determination of finger blood flow and skin temperature in the fingers of patients with moderate to severe Raynaud's phenomenon, follwoing… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Raynaud Disease, Raynaud Disease Secondary to Scleroderma, Raynaud Secondary to Other Autoimmune Disease
- What is being tested?
- topical organogel with nitroglycerin
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2004to Sep 2005
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of Raynaud's phenomenon
- outpoatients
- agree to apply gel as per protocol
- willing to discontinue current vasodilator therapy
- agree to stop other investigational medication for Raynaud's
- negative pregnancy test is fertile females
- able to give written informed consent and comply with study requirements
Who cannot join
- current use of ay nitrate medication or medications that interact with nitroglycerin
- patients with a known allergy to nitroglycerin or topical gel ingredients
- patients with a history of migraine headaches
- patients with unstable medical problems
- patients with cognitive or language difficulties
- patients with screening lab values more than 20% outside of normal
- patients with open lesions at site of application
- women of child-bearing potential who are unwilling to comply with contraceptive requirements.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
University of Washington Medical College
Seattle, Washington, 98195
About this study
Official title: Phase III Laboratory Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, in the Treatment of Raynaud's Phenomenon
The purpose of this study is to determine, in comparison to a placebo control, the response to two dosage strengths of a topical gel formulation of nitroglycerin, MQX-303, in the determination of finger blood flow and skin temperature in the fingers of patients with moderate to severe Raynaud's phenomenon, follwoing exposure to cold temperatures.
Blood flow is determined by scanning laser Doppler equipment and skin temperature is measured using attached thermistor probes. Following baseline measurements, the study gel is applied, the hand is placed in a cold chamber, and then blood flow and skin temperature are monitored for the next two hours.
Each patient will receive multiple doses on different days so that each can serve as his/her own control in interpreting the response.
- Conditions
- Raynaud Disease, Raynaud Disease Secondary to Scleroderma, Raynaud Secondary to Other Autoimmune Disease
- Being tested
- topical organogel with nitroglycerin
- Keywords
- Raynaud's, sclerderma, systemic sclerosis, autoimmune disease
- Medical subject headings
- Raynaud Disease, Scleroderma, Systemic, Autoimmune Diseases
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.
Differntial time for blood flow to return to baseline following cold exposure.
Secondary outcomes (2)
Differential time for skin temperature to return to baseline following cold exposure.
Quantitative reduction or prevention in symptoms following cold exposure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startNov 2004
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Raynaud 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- MediQuest Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Laura K Hummers, MD, Principal investigator, Johns Hopkins UniversityCarin Dugowson, MD, MPH, Principal investigator, University of Washington Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253331
- Sponsor's protocol ID
- MQT 03-001
- Status last verified
- May 2007
- First submitted
- 13 Nov 2005
- 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 Laboratory Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, in the Treatment of Raynaud's Phenomenon
- ClinicalTrials.gov ID
- NCT00253331
- Acronym / sponsor ID
- MQT 03-001
- Conditions
- Raynaud Disease, Raynaud Disease Secondary to Scleroderma, Raynaud Secondary to Other Autoimmune Disease
- Keywords
- Raynaud's, sclerderma, systemic sclerosis, autoimmune disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- MediQuest TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Study completion
- Sep 2005
- First posted
- 15 Nov 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 determine, in comparison to a placebo control, the response to two dosage strengths of a topical gel formulation of nitroglycerin, MQX-303, in the determination of finger blood flow and skin temperature in the fingers of patients with moderate to severe Raynaud's phenomenon, follwoing exposure to cold temperatures.
Blood flow is determined by scanning laser Doppler equipment and skin temperature is measured using attached thermistor probes. Following baseline measurements, the study gel is applied, the hand is placed in a cold chamber, and then blood flow and skin temperature are monitored for the next two hours.
Each patient will receive multiple doses on different days so that each can serve as his/her own control in interpreting the response.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- clinical diagnosis of Raynaud's phenomenon
- outpoatients
- agree to apply gel as per protocol
- willing to discontinue current vasodilator therapy
- agree to stop other investigational medication for Raynaud's
Key exclusion criteria (8 listed)
- current use of ay nitrate medication or medications that interact with nitroglycerin
- patients with a known allergy to nitroglycerin or topical gel ingredients
- patients with a history of migraine headaches
- patients with unstable medical problems
- patients with cognitive or language difficulties
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
Differntial time for blood flow to return to baseline following cold exposure.
2 secondary outcomes
Differential time for skin temperature to return to baseline following cold exposure.
Quantitative reduction or prevention in symptoms following cold exposure.
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.
Laura K Hummers, MD principal investigator
Johns Hopkins University
Carin Dugowson, MD, MPH principal investigator
University of Washington Medical College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing topical organogel with nitroglycerin in people with Raynaud Disease and Raynaud Disease Secondary to Scleroderma, run by MediQuest Therapeutics at 2 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 8 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 2 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Differntial time for blood flow to return to baseline following cold exposure.. 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.