Raynaud DiseasePhase 3NCT00934427
Study of a Topical Formulation for the Treatment and Prevention of Raynaud's Phenomenon Symptoms
A Phase 3 study testing 0.9% nitroglycerin in TAM cream in people with Raynaud Disease, run by MediQuest Therapeutics at 11 sites in United States.
Trial summary
The purpose of this study is to determine if Vascana, a novel topical formulation of nitroglycerin, is effective in the treatment and prevention of the symptoms associated with Raynaud's Phenomenon. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Raynaud Disease
- What is being tested?
- 0.9% nitroglycerin in TAM cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 11 sitesUnited States
- Study dates
- Jun 2009to Jul 2010
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of Raynaud's phenomenon as determined by a history of cold sensitivity with pain, numbness, and/or tingling along with pallor or cyanosis of the fingers
- a history of at least two Raynaud's events during a typical winter day
- must be willing to apply creams to fingers
- must be willing to undergo cold temperature exposure
- must be willing and able to stop certain medications
- must be willing to use effective contraception, if applicable
Who cannot join
- had a Raynaud's attack that required hospital or clinic intervention
- has allergies to nitroglycerin or topical medication ingredients
- has a history of migraine or chronic pain
- has an unstable medical problem that could interfere with the study
- had a heart attack or uncontrolled heart problems, hypertension, or hypotension in the past 3 months
- used any investigational drug in the past 4 weeks
Show all 10Show fewer
- has significantly abnormal laboratory tests
- had certain major surgeries in the past 6 months
- has skin lesions on certain parts of the fingers
- women who are pregnant or nursing
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Michigan
Ann Arbor, Michigan, 48106
Massachusetts General Hospital
Boston, Massachusetts, 02114
Cleveland Clinic
Cleveland, Ohio, 44195
University of Connecticut
Farmington, Connecticut, 06030
Michigan State University
Grand Rapids, Michigan, 49546
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
University of Medicine and Dentistry in New Jersey
New Brunswick, New Jersey, 08903
Stanford University
Redwood City, California, 94063
University of Toledo
Toledo, Ohio, 43614
Carolina Arthritis
Wilmington, North Carolina, 28401
About this study
Official title: A Study of a Topical Formulation of Nitroglycerin, Vascana® (MQX-503), and Matching Vehicle in the Treatment and Prevention of Symptoms Associated With Raynaud's Phenomenon
The purpose of this study is to determine if Vascana, a novel topical formulation of nitroglycerin, is effective in the treatment and prevention of the symptoms associated with Raynaud's Phenomenon.
Read the detailed description
Raynaud's Phenomenon is a sometimes debilitating condition in which blood flow to the fingers or toes is compromised when a patient is exposed to cold or stress. Current therapies for Raynaud's are suboptimal because they are associated with significant side effects. In this study, patient responses to cold temperature exposures in a climate-controlled room after application of the study medication are measured.
- Conditions
- Raynaud Disease
- Being tested
- 0.9% nitroglycerin in TAM cream, vehicle cream
- Keywords
- Raynaud's, scleroderma, nitroglycerin, MQX-503, treatment
- 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.
0.9% nitroglycerin in TAM creamDrug
Also called Vascana
0.5 g of Vascana (0.9% nitroglycerin in proprietary vehicle cream) is applied topically BID for one day before certain planned cold exposures, once just before same planned cold exposures, and, if needed, right after the start of symptoms during same planned cold exposures
vehicle creamDrug
0.5g of vehicle cream is topically administered BID for one day before certain planned cold exposures, once just before certain planned cold exposures, and, if needed, right after the start of symptoms during certain planned cold exposures
| Study group | Role | What they receive |
|---|---|---|
| Vascana | Active comparator | Not described Receives: Drug: 0.9% nitroglycerin in TAM cream |
| Vehicle | Placebo comparator | Not described Receives: Drug: vehicle cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate as measured by changes in severity of the Raynaud's symptom most bothersome to the individual patient (Pain, Numbness, or Tingling)
Measured: 2 weeks
Secondary outcomes (7)
Changes from baseline in severity of each Raynaud's symptom (Pain, Numbness, and Tingling)
Measured: 2 weeks
Changes from baseline in duration of Raynaud's attacks
Measured: 2 weeks
Changes from baseline in number of Raynaud's attacks
Measured: 2 weeks
Changes from baseline in the Raynaud's Condition Score
Measured: 2 weeks
Changes in the maximum reduction in skin temperature
Measured: 2 weeks
Changes from baseline in overall disease severity measures
Measured: 2 weeks
Changes in the time to return to baseline skin temperature
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2010 (estimated)
- Study completionJul 2010 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MediQuest Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jeff Gregory, MD, Study director, MediQuest Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934427
- Sponsor's protocol ID
- 09-001
- Status last verified
- Jul 2010
- First submitted
- 26 Jun 2009
- Last updated
- 20 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of a Topical Formulation of Nitroglycerin, Vascana® (MQX-503), and Matching Vehicle in the Treatment and Prevention of Symptoms Associated With Raynaud's Phenomenon
- ClinicalTrials.gov ID
- NCT00934427
- Acronym / sponsor ID
- 09-001
- Conditions
- Raynaud Disease
- Keywords
- Raynaud's, scleroderma, nitroglycerin, MQX-503, treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- MediQuest TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 8 Jul 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 study is to determine if Vascana, a novel topical formulation of nitroglycerin, is effective in the treatment and prevention of the symptoms associated with Raynaud's Phenomenon.
Detailed description
Raynaud's Phenomenon is a sometimes debilitating condition in which blood flow to the fingers or toes is compromised when a patient is exposed to cold or stress. Current therapies for Raynaud's are suboptimal because they are associated with significant side effects. In this study, patient responses to cold temperature exposures in a climate-controlled room after application of the study medication are measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vascana | Active comparator | Drug: 0.9% nitroglycerin in TAM cream |
| Vehicle | Placebo comparator | Drug: vehicle cream |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- clinical diagnosis of Raynaud's phenomenon as determined by a history of cold sensitivity with pain, numbness, and/or tingling along with pallor or cyanosis of the fingers
- a history of at least two Raynaud's events during a typical winter day
- must be willing to apply creams to fingers
- must be willing to undergo cold temperature exposure
- must be willing and able to stop certain medications
Key exclusion criteria (10 listed)
- had a Raynaud's attack that required hospital or clinic intervention
- has allergies to nitroglycerin or topical medication ingredients
- has a history of migraine or chronic pain
- has an unstable medical problem that could interfere with the study
- had a heart attack or uncontrolled heart problems, hypertension, or hypotension in the past 3 months
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 |
|---|---|---|
| 0.9% nitroglycerin in TAM creamAlso: Vascana0.5 g of Vascana (0.9% nitroglycerin in proprietary vehicle cream) is applied topically BID for one day before certain planned cold exposures, once just before same planned cold exposures, and, if needed, right after the start of symptoms during same planned cold exposures | Drug | Vascana |
| vehicle cream0.5g of vehicle cream is topically administered BID for one day before certain planned cold exposures, once just before certain planned cold exposures, and, if needed, right after the start of symptoms during certain planned cold exposures | Drug | Vehicle |
Primary outcome
Response rate as measured by changes in severity of the Raynaud's symptom most bothersome to the individual patient (Pain, Numbness, or Tingling)
Time frame: 2 weeks
7 secondary outcomes
Changes from baseline in severity of each Raynaud's symptom (Pain, Numbness, and Tingling)
Time frame: 2 weeks
Changes from baseline in duration of Raynaud's attacks
Time frame: 2 weeks
Changes from baseline in number of Raynaud's attacks
Time frame: 2 weeks
Changes from baseline in the Raynaud's Condition Score
Time frame: 2 weeks
Changes in the maximum reduction in skin temperature
Time frame: 2 weeks
Changes from baseline in overall disease severity measures
Time frame: 2 weeks
Changes in the time to return to baseline skin temperature
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2010.
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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.
Jeff Gregory, MD study director
MediQuest Therapeutics
11 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 0.9% nitroglycerin in TAM cream in people with Raynaud Disease, run by MediQuest Therapeutics at 11 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 6 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: status not confirmed, as of the sponsor's last update on 20 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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. Some participants in this study may receive a placebo. 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?
Response rate as measured by changes in severity of the Raynaud's symptom most bothersome to the individual patient (Pain, Numbness, or Tingling) (time frame: 2 weeks). 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 20 Jul 2010.