Raynaud's Phenomenon Secondary to Connective Tissue DiseasePhase 2NCT02688270
Efficacy and Safety of Vascana® in Subjects With Secondary Raynaud's Phenomenon
A Phase 2 study testing Vascana (0.9% nitroglycerin cream) in people with Raynaud's Phenomenon Secondary to Connective Tissue Disease, run by Covis Pharma S.à.r.l. at 1 site in United States.
Trial summary
The purpose of this study is to determine the ability of Vascana (0.9% nitroglycerin topical cream) to treat and prevent the symptoms experienced by subject's with Raynaud's Phenomenon. The symptoms of this disease include pain, tingling, and numbness in the fingers of the affected hand or hands. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Raynaud's Phenomenon Secondary to Connective Tissue Disease
- What is being tested?
- Vascana (0.9% nitroglycerin cream)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Dec 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written consent prior to any study-specific evaluation
- Males and females aged 18 years to 75 years, inclusive
- A clinical diagnosis of secondary Raynaud's Phenomenon (defined as Raynaud's Phenomenon (RP) significant enough to cause a patient to modify daily behavior) as determined by a history of cold sensitivity with pain, numbness, and/or tingling along with pallor or cyanosis of the fingers, or by such an event observed by the study physician and a diagnosis of a disease state known to be associated with RP. Secondary RP may be due to scleroderma, systemic lupus erythematosus, mixed connective tissue disease, or other connective tissue diseases
- Agree to apply the study drug to their fingers as specified in the protocol
- Agree to the controlled cold exposures as described in the protocol
- Willing to discontinue current vasodilator therapies used specifically for the treatment of Raynaud's
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- Agree not to use any other investigational medications or approved or unapproved therapies to treat RP and its symptoms while participating in this study. Such medications include, but are not limited to: other dosages forms of nitroglycerin, eg, isosorbide dinitrate, fenoldopam mesylate, milrinone lactate, nifedipine, diltiazem, felodipine, nimodipine, nisoldipine, fluoxetine, pregabalin, and verapamil. Use of phosphodiesterase 5 inhibitors (eg, sildenafil, tadalafil, vardenafil) is excluded unless being used intermittently for male erectile dysfunction and not taken within 48 hours of scheduled study drug dosing
- Negative urine pregnancy test for women of child-bearing potential prior to the first study treatment and who agree to use effective contraception throughout the study
- Able to comply with all study requirements
Who cannot join
- Past history of RP attacks of sufficient severity as to require inpatient hospitalization
- Presence of an active digital ulcer defined as a painful ulcer with visible depth and loss of epithelialization. Ulcers covered with eschar wherein depth and epithelialization cannot be judged are said to be "indeterminant" and are not exclusionary.
- Raynaud's Phenomenon secondary to non-connective tissue disorders including thromboangiitis obliterans (Buerger's disease), hemorheologic disorders, major arterial occlusive disease, past exposure to vasopathic agents (including vinblastine, cis platinum, and bleomycin), ongoing therapy with vasoconstrictive agents (eg, beta-blockers), and past frostbite injury amongst others. Subjects with hepatitis C should also be excluded.
- Patients diagnosed with pulmonary arterial hypertension requiring specific therapy.
- Concurrently using any nitrate medication or medications known to interact with nitroglycerin such as sildenafil, and other treatments for erectile dysfunction beyond screening. Subjects may participate in the study once these drugs have been discontinued for at least 5 half-lives
- Concurrently using any medication or device which might interfere with the study medication (including RP therapies, drugs used for hypertension, arrhythmia, depression, and pain), specifically calcium channel blockers and the compounds listed in prohibited concomitant medications beyond screening, unless such medication is required for a condition other than Raynaud's. Subjects may participate in the study once these drugs have been discontinued for at least 5 half-lives.
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- Known allergy to nitroglycerin or common topical cream ingredients
- History of migraine, cluster, or vascular headaches, or chronic pain (defined as pain of 3-hour duration or longer on a daily basis) with greater intensity than the pain associated with RP or other chronic pain condition in their fingers
- Any unstable medical problem or any current medical condition that, in the judgment of the investigator, would contraindicate the administration of the study medication, interfere with the study evaluations, or interfere with the subject's ability to comply with the study protocol
- Cognitive or language difficulties that would impair completion of the symptom assessment instruments
- Within the past 3 months, have had a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension, or uncontrolled hypertension (defined as subjects not being treated medically to control these conditions)
- Participated in a study of any investigational drug within 4 weeks prior to visit 1
- Screening laboratory values are 20% or more from the upper or lower limit of normal and that are considered to be clinically significant to the investigator
- Had major abdominal, thoracic, or vascular surgery within 6 months of visit 1
- Pregnant or nursing women
- Women of childbearing potential who are unable or unwilling to comply with the contraceptive requirements during the study period
- History of relevant drug and/or food allergies that resulted in a systemic reaction that required medical treatment
- History of alcohol abuse or drug addiction which in the estimation of the principal investigator would affect the subjects ability to participate in the study
- Consumption of alcohol on day before a visit and day of the visit.
- Consumption of two or more alcoholic beverages on a daily basis.
- Use of tobacco products of any type and at any level in the preceding 6 months and for the duration of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Multiple investigational sites
Multiple Locations, Pennsylvania
About this study
Official title: A Double-blinded Crossover Study of Topical Formulation of Nitroglycerine, Vascana®, Versus Matching Vehicle in the Subjective and Physiologic Responses to Controlled Cold Challenge in Subjects With Raynaud's Phenomenon (RP) Secondary to Connective Tissue Disease
The purpose of this study is to determine the ability of Vascana (0.9% nitroglycerin topical cream) to treat and prevent the symptoms experienced by subject's with Raynaud's Phenomenon. The symptoms of this disease include pain, tingling, and numbness in the fingers of the affected hand or hands.
- Being tested
- Vascana (0.9% nitroglycerin cream), Vehicle Cream (placebo)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascana (0.9% nitroglycerin cream)Drug
Study drug administered topically
Vehicle Cream (placebo)Drug
Vehicle administered topically
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence A | Experimental | Vascana® (0.9% nitroglycerin cream), Vehicle cream, Vascana® (0.9% nitroglycerin cream), Vehicle cream Receives: Drug: Vascana (0.9% nitroglycerin cream); Drug: Vehicle Cream (placebo) |
| Treatment Sequence B | Experimental | Vascana® (0.9% nitroglycerin cream), Vehicle cream, Vehicle cream, Vascana® (0.9% nitroglycerin cream) Receives: Drug: Vascana (0.9% nitroglycerin cream); Drug: Vehicle Cream (placebo) |
| Treatment Sequence C | Experimental | Vehicle cream, Vascana® (0.9% nitroglycerin cream), Vehicle cream, Vascana® (0.9% nitroglycerin cream) Receives: Drug: Vascana (0.9% nitroglycerin cream); Drug: Vehicle Cream (placebo) |
| Treatment Sequence D | Experimental | Vehicle cream, Vascana® (0.9% nitroglycerin cream), Vascana® (0.9% nitroglycerin cream), Vehicle cream Receives: Drug: Vascana (0.9% nitroglycerin cream); Drug: Vehicle Cream (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Raynaud's Symptom Severity (Change From Baseline)
Change from baseline to visit 6 in peak Main Raynaud's Symptom (MRS) severity. Raynaud's symptoms will be assessed separately using a 0 to100-mm Visual Analog Scale (VAS) for pain, numbness, and tingling where 0 mm = no symptom and 100 mm = most severe symptom.
Measured: 6 weeks
Raynaud's Symptom Severity (Percentage of Responders)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Raynaud's Phenomenon Secondary to Connective Tissue 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Covis Pharma S.à.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688270
- Sponsor's protocol ID
- VAS-014-001
- Status last verified
- Oct 2022
- First submitted
- 18 Feb 2016
- Last updated
- 2 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blinded Crossover Study of Topical Formulation of Nitroglycerine, Vascana®, Versus Matching Vehicle in the Subjective and Physiologic Responses to Controlled Cold Challenge in Subjects With Raynaud's Phenomenon (RP) Secondary to Connective Tissue Disease
- ClinicalTrials.gov ID
- NCT02688270
- Acronym / sponsor ID
- VAS-014-001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Covis Pharma S.à.r.l.Industry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 23 Feb 2016 (estimated)
- Results
- Posted 2 Nov 2022
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 ability of Vascana (0.9% nitroglycerin topical cream) to treat and prevent the symptoms experienced by subject's with Raynaud's Phenomenon. The symptoms of this disease include pain, tingling, and numbness in the fingers of the affected hand or hands.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence A | Experimental | Drug: Vascana (0.9% nitroglycerin cream), Drug: Vehicle Cream (placebo)Vascana® (0.9% nitroglycerin cream), Vehicle cream, Vascana® (0.9% nitroglycerin cream), Vehicle cream |
| Treatment Sequence B | Experimental | Drug: Vascana (0.9% nitroglycerin cream), Drug: Vehicle Cream (placebo)Vascana® (0.9% nitroglycerin cream), Vehicle cream, Vehicle cream, Vascana® (0.9% nitroglycerin cream) |
| Treatment Sequence C | Experimental | Drug: Vascana (0.9% nitroglycerin cream), Drug: Vehicle Cream (placebo)Vehicle cream, Vascana® (0.9% nitroglycerin cream), Vehicle cream, Vascana® (0.9% nitroglycerin cream) |
| Treatment Sequence D | Experimental | Drug: Vascana (0.9% nitroglycerin cream), Drug: Vehicle Cream (placebo)Vehicle cream, Vascana® (0.9% nitroglycerin cream), Vascana® (0.9% nitroglycerin cream), Vehicle cream |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provide written consent prior to any study-specific evaluation
- Males and females aged 18 years to 75 years, inclusive
- A clinical diagnosis of secondary Raynaud's Phenomenon (defined as Raynaud's Phenomenon (RP) significant enough to cause a patient to modify daily behavior) as determined by a history of cold sensitivity with pain, numbness, and/or tingling along with pallor or cyanosis of the fingers, or by such an event observed by the study physician and a diagnosis of a disease state known to be associated with RP. Secondary RP may be due to scleroderma, systemic lupus erythematosus, mixed connective tissue disease, or other connective tissue diseases
- Agree to apply the study drug to their fingers as specified in the protocol
- Agree to the controlled cold exposures as described in the protocol
Key exclusion criteria (21 listed)
- Past history of RP attacks of sufficient severity as to require inpatient hospitalization
- Presence of an active digital ulcer defined as a painful ulcer with visible depth and loss of epithelialization. Ulcers covered with eschar wherein depth and epithelialization cannot be judged are said to be "indeterminant" and are not exclusionary.
- Raynaud's Phenomenon secondary to non-connective tissue disorders including thromboangiitis obliterans (Buerger's disease), hemorheologic disorders, major arterial occlusive disease, past exposure to vasopathic agents (including vinblastine, cis platinum, and bleomycin), ongoing therapy with vasoconstrictive agents (eg, beta-blockers), and past frostbite injury amongst others. Subjects with hepatitis C should also be excluded.
- Patients diagnosed with pulmonary arterial hypertension requiring specific therapy.
- Concurrently using any nitrate medication or medications known to interact with nitroglycerin such as sildenafil, and other treatments for erectile dysfunction beyond screening. Subjects may participate in the study once these drugs have been discontinued for at least 5 half-lives
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 |
|---|---|---|
| Vascana (0.9% nitroglycerin cream)Study drug administered topically | Drug | Treatment Sequence A, Treatment Sequence B, Treatment Sequence C, Treatment Sequence D |
| Vehicle Cream (placebo)Vehicle administered topically | Drug | Treatment Sequence A, Treatment Sequence B, Treatment Sequence C, Treatment Sequence D |
Primary outcome
Raynaud's Symptom Severity (Change From Baseline)
Time frame: 6 weeks
Change from baseline to visit 6 in peak Main Raynaud's Symptom (MRS) severity. Raynaud's symptoms will be assessed separately using a 0 to100-mm Visual Analog Scale (VAS) for pain, numbness, and tingling where 0 mm = no symptom and 100 mm = most severe symptom.
Raynaud's Symptom Severity (Percentage of Responders)
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 2 study testing Vascana (0.9% nitroglycerin cream) in people with Raynaud's Phenomenon Secondary to Connective Tissue Disease, run by Covis Pharma S.à.r.l. 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 9 inclusion and 21 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 2 Nov 2022. 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?
Yes. Results are posted in the registry (first posted 2 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Raynaud's Symptom Severity (Change From Baseline) (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 2 Nov 2022.