Raynaud's DiseasePhase 2NCT00378521
Dose Response Study of a Topical Gel for the Treatment of Raynaud's Phenomenon
A Phase 2 study testing MQX-503 in people with Raynaud's Disease and Raynaud's Disease Secondary to Scleroderma, run by MediQuest Therapeutics at 1 site in United States.
Trial summary
The Purpose of this study is to determine the response to two different strengths of a topical gel containing nitroglycerin in patients with Raynaud's disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Raynaud's Disease, Raynaud's Disease Secondary to Scleroderma, Raynaud's Disease Secondary to Autoimmune Disease
- What is being tested?
- MQX-503
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Jul 2006
- Phase
- Phase 2
- 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 75 years
- All sexes
- Adult, Older adult
Who may be able to join
- Outpatients, 18 to 75 years
- Clinical Diagnosis of Raynaud's, or observed event by study physician, or symptoms with reduced blood flow as meausred using laser doppler equipment
- Agree to have test gels applied to finger
- Discontinue current vasodialator therapeis for Raynaud's treatment
- Four weeks from last clinical trial participation
- Agree not to use any other investigational medications or therapies to treat Raynaud's and its symptoms while participating in this study including other dosages or forms of nitroglycerin, isosorbide dinitrate, fenoldopam mesylate, milrinone lactate, nifedipine, diltiazem, felodipine, nimodipine, nisoldipine, and verapamil
- Negative pregnancy test for women prior to study start and agree to use effective contraception throughout
- Must be able to give written informed consent and comply with all study requirements
Who cannot join
- Concurrent use of any nitrate medication or medications known to interact with Nitroglycerin such as sildenafil, and other treatments for erectile dysfunction
- Patients who have a known allergy to Nitroglycerin or common topical gel ingredients
- Patients with a history of migraine, cluster or vascular headaches, or those who suffer from chronic pain
- Patients with a history of an unstable medical problem or any current condition that would interfere in participation in the study
- Patients unable to complete pain assessment instructions
- Patients who in the last three months have had a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension or uncontrolled hypertension
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- Patients who have participated in another investigational drug study within four weeks of the first study treatment
- Patients with out of range laboratory screening values
- Patients who have had major abdominal, thoracic or vascular surgery within six months of the first study treatment
- Patients with open lesions or skin conditions where gel is to be applied
- Pregnant or nursing women
- Women who will not agree to comply with contraceptive requirements
- Patients with a history of poor compliance, poor cooperation or unreliability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Dose Response 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 the response to two different strengths of a topical gel containing nitroglycerin in patients with Raynaud's disease.
Read the detailed description
The Purpose of this clinical study is to determine, in a controlled fashion, the response to two dosage strengths of a topical gel formulation of Nitroglycerin, MQX-503, in the determination of changes in finger blood flow and skin temperature in the fingers of patients with moderate to severe primary Raynaud's phenomenon and with Raynaud's phenomenon secondary to autoimmune diseases, such as scleroderma. The dosage strength response in the treatment of the symptoms (pain, tingling, numbness) will also be monitored.
- Conditions
- Raynaud's Disease, Raynaud's Disease Secondary to Scleroderma, Raynaud's Disease Secondary to Autoimmune Disease
- Being tested
- MQX-503
- Keywords
- Raynaud's, Nitroglycerin, topical gel, cold hands, painful hands, 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.
MQX-503Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the time required for blood flow to return to baseline after cold exposure
Secondary outcomes (2)
Measure the time required for skin temperature to return to baseline after cold exposure
Prevention or reduction of 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 posted20 Sep 2006 (estimated)
- Study startJul 2006
- Study completionJul 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MediQuest Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Leslie Klaff, MD, Principal investigator, Rainier Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378521
- Sponsor's protocol ID
- 06-001
- Status last verified
- May 2007
- First submitted
- 18 Sep 2006
- 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 II Dose Response Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, in the Treatment of Raynaud's Phenomenon
- ClinicalTrials.gov ID
- NCT00378521
- Acronym / sponsor ID
- 06-001
- Conditions
- Raynaud's Disease, Raynaud's Disease Secondary to Scleroderma, Raynaud's Disease Secondary to Autoimmune Disease
- Keywords
- Raynaud's, Nitroglycerin, topical gel, cold hands, painful hands, scleroderma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- MediQuest TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Study completion
- Jul 2006 (actual)
- First posted
- 20 Sep 2006 (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 the response to two different strengths of a topical gel containing nitroglycerin in patients with Raynaud's disease.
Detailed description
The Purpose of this clinical study is to determine, in a controlled fashion, the response to two dosage strengths of a topical gel formulation of Nitroglycerin, MQX-503, in the determination of changes in finger blood flow and skin temperature in the fingers of patients with moderate to severe primary Raynaud's phenomenon and with Raynaud's phenomenon secondary to autoimmune diseases, such as scleroderma. The dosage strength response in the treatment of the symptoms (pain, tingling, numbness) will also be monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Outpatients, 18 to 75 years
- Clinical Diagnosis of Raynaud's, or observed event by study physician, or symptoms with reduced blood flow as meausred using laser doppler equipment
- Agree to have test gels applied to finger
- Discontinue current vasodialator therapeis for Raynaud's treatment
- Four weeks from last clinical trial participation
Key exclusion criteria (13 listed)
- Concurrent use of any nitrate medication or medications known to interact with Nitroglycerin such as sildenafil, and other treatments for erectile dysfunction
- Patients who have a known allergy to Nitroglycerin or common topical gel ingredients
- Patients with a history of migraine, cluster or vascular headaches, or those who suffer from chronic pain
- Patients with a history of an unstable medical problem or any current condition that would interfere in participation in the study
- Patients unable to complete pain assessment instructions
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 |
|---|---|---|
| MQX-503 | Drug | – |
Primary outcome
Measure the time required for blood flow to return to baseline after cold exposure
2 secondary outcomes
Measure the time required for skin temperature to return to baseline after cold exposure
Prevention or reduction of 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.
Leslie Klaff, MD principal investigator
Rainier Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MQX-503 in people with Raynaud's Disease and Raynaud's Disease Secondary to Scleroderma, run by MediQuest Therapeutics at 1 site 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 8 inclusion and 13 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 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Measure the time required for blood flow to return to baseline after 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.