Raynaud's PhenomenonPhase 1NCT00841594
MQX-503 Applied to the Hand Versus Nitroglycerin Ointment Applied to the Chest: A Pharmacokinetic Comparison
A Phase 1 study testing nitroglycerin 0.9 % (MXQ-503) and Nitroglycerin ointment 2%, USP in people with Raynaud's Phenomenon, run by MediQuest Therapeutics at 1 site in United States.
Trial summary
The purpose of this clinical study is to compare the pharmacokinetic profiles of a topical cream formulation of 0.9% nitroglycerin, MQX 503, and Nitroglycerin Ointment 2%, USP. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Raynaud's Phenomenon
- What is being tested?
- nitroglycerin 0.9 % (MXQ-503) and Nitroglycerin ointment 2%, USP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Mar 2009
- Phase
- Phase 1
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 50 years of age
- Subjects who do not take any prescription medication or who can safely discontinue use prior to visit 1.
- Negative pregnancy test for fertile women and agree to use effective contaception throughout the study.
Who cannot join
- Subjects who can not safely discontinue current prescription medications.
- Subjects who have a known allergy to nitroglycerin or common topical formulation ingredients.
- Subjects with an unstable medical problem.
- Subjects who, within the past three months, have had either a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension, or uncontrolled hypertension.
- Subjects who participated in a study of any investigational drug or device within four weeks prior to Visit 1.
- Subjects who have screening laboratory values which are outside the normal range and which are considered to be clinically significant to the investigator.
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- Subjects who have had major abdominal, thoracic, or vascular surgery within six months of Visit 1.
- Subjects with non-epithelialized skin lesions or interfering skin conditions at time of screening in the area where either study medication is to be applied.
- Pregnant or nursing women.
- Women of childbearing potential who are unable or unwilling to comply with the contraceptive requirements during the study period.
Trial locations and contacts
1 site in 1 country.
United States1 site
Charles River Clinical Services
Tacoma, Washington, 98418
About this study
Official title: MXQ-503 Applied To The Hand Vs. Nitroglycerin Ointment 2%, USP, Applied To The Chest: A Pharmacokinetic Comparison In Normal Subjects
The purpose of this clinical study is to compare the pharmacokinetic profiles of a topical cream formulation of 0.9% nitroglycerin, MQX 503, and Nitroglycerin Ointment 2%, USP.
- Conditions
- Raynaud's Phenomenon
- Being tested
- nitroglycerin 0.9 % (MXQ-503), Nitroglycerin ointment 2%, USP
- Keywords
- healthy volunteers
- Medical subject headings
- Raynaud Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nitroglycerin 0.9 % (MXQ-503)Drug
MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.
Nitroglycerin ointment 2%, USPDrug
MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.
Applied to the hand. Receives: Drug: nitroglycerin 0.9 % (MXQ-503) |
| 2 | Active comparator | MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.
Applied to the chest. Receives: Drug: Nitroglycerin ointment 2%, USP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement and comparison of the levels of nitroglycerin and its dinitrate metabolites in the blood of healthy human volunteers after a single topical dose of MQX 503 and a single topical dose of Nitroglycerin Ointment 2%, USP.
Measured: 12 hours
Secondary outcomes (1)
Observation for any adverse events such as headache.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Raynaud's PhenomenonStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MediQuest Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841594
- Sponsor's protocol ID
- 08-001
- Status last verified
- May 2011
- First submitted
- 9 Feb 2009
- Last updated
- 17 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MXQ-503 Applied To The Hand Vs. Nitroglycerin Ointment 2%, USP, Applied To The Chest: A Pharmacokinetic Comparison In Normal Subjects
- ClinicalTrials.gov ID
- NCT00841594
- Acronym / sponsor ID
- 08-001
- Conditions
- Raynaud's Phenomenon
- Keywords
- healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- MediQuest TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 11 Feb 2009 (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 clinical study is to compare the pharmacokinetic profiles of a topical cream formulation of 0.9% nitroglycerin, MQX 503, and Nitroglycerin Ointment 2%, USP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: nitroglycerin 0.9 % (MXQ-503)MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP. Applied to the hand. |
| 2 | Active comparator | Drug: Nitroglycerin ointment 2%, USPMQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP. Applied to the chest. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 to 50 years of age
- Subjects who do not take any prescription medication or who can safely discontinue use prior to visit 1.
- Negative pregnancy test for fertile women and agree to use effective contaception throughout the study.
Key exclusion criteria (10 listed)
- Subjects who can not safely discontinue current prescription medications.
- Subjects who have a known allergy to nitroglycerin or common topical formulation ingredients.
- Subjects with an unstable medical problem.
- Subjects who, within the past three months, have had either a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension, or uncontrolled hypertension.
- Subjects who participated in a study of any investigational drug or device within four weeks prior to Visit 1.
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 |
|---|---|---|
| nitroglycerin 0.9 % (MXQ-503)MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP. | Drug | 1 |
| Nitroglycerin ointment 2%, USPMQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP. | Drug | 2 |
Primary outcome
Measurement and comparison of the levels of nitroglycerin and its dinitrate metabolites in the blood of healthy human volunteers after a single topical dose of MQX 503 and a single topical dose of Nitroglycerin Ointment 2%, USP.
Time frame: 12 hours
1 secondary outcome
Observation for any adverse events such as headache.
Time frame: 3 weeks
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 17 May 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing nitroglycerin 0.9 % (MXQ-503) and Nitroglycerin ointment 2%, USP in people with Raynaud's Phenomenon, 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 3 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 17 May 2011. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Measurement and comparison of the levels of nitroglycerin and its dinitrate metabolites in the blood of healthy human volunteers after a single topical dose of MQX 503 and a single topical dose of Nitroglycerin Ointment 2%, USP. (time frame: 12 hours). 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 17 May 2011.