- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02688270
Efficacy and Safety of Vascana® in Subjects With Secondary Raynaud's Phenomenon
October 11, 2022 updated by: Covis Pharma S.à.r.l.
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Multiple Locations, Pennsylvania, United States
- Multiple Investigational Sites
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Sequence A
Vascana® (0.9% nitroglycerin cream), Vehicle cream, Vascana® (0.9% nitroglycerin cream), Vehicle cream
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Study drug administered topically
Vehicle administered topically
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Experimental: Treatment Sequence B
Vascana® (0.9% nitroglycerin cream), Vehicle cream, Vehicle cream, Vascana® (0.9% nitroglycerin cream)
|
Study drug administered topically
Vehicle administered topically
|
Experimental: Treatment Sequence C
Vehicle cream, Vascana® (0.9% nitroglycerin cream), Vehicle cream, Vascana® (0.9% nitroglycerin cream)
|
Study drug administered topically
Vehicle administered topically
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Experimental: Treatment Sequence D
Vehicle cream, Vascana® (0.9% nitroglycerin cream), Vascana® (0.9% nitroglycerin cream), Vehicle cream
|
Study drug administered topically
Vehicle administered topically
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 weeks
|
Raynaud's Symptom Severity (Percentage of Responders)
Time Frame: 6 weeks
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6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
February 18, 2016
First Submitted That Met QC Criteria
February 22, 2016
First Posted (Estimate)
February 23, 2016
Study Record Updates
Last Update Posted (Actual)
November 2, 2022
Last Update Submitted That Met QC Criteria
October 11, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VAS-014-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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