Dose Response to Topical Glyceryl Trinitrate in Patients With Raynaud's Phenomenon
NCT ID: NCT00700518
Last Updated: 2008-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2008-06-30
2008-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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1.
placebo cream applied to 2 adjacent fingers on non-dominant hand one time
placebo cream
placebo cream applied to 2 adjacent fingers of non-dominant hand one time
2
0.6mg of Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand
Glyceryl Trinitrate
0.6mg of Glyceryl Trinitrate applied to 2 adjacent fingers on non-dominant hand one time
3
1.2mg of Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time
Glyceryl Trinitrate
1.2mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time
4
1.8mg Glyceryl Trinitrate topically to 2 adjacent fingers on non-dominant hand one time
Glyceryl Trinitrate
1.8mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time
5
2.4 mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time
Glyceryl Trinitrate
2.4 mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time
Interventions
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placebo cream
placebo cream applied to 2 adjacent fingers of non-dominant hand one time
Glyceryl Trinitrate
0.6mg of Glyceryl Trinitrate applied to 2 adjacent fingers on non-dominant hand one time
Glyceryl Trinitrate
1.2mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time
Glyceryl Trinitrate
1.8mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time
Glyceryl Trinitrate
2.4 mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time
Eligibility Criteria
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Inclusion Criteria
* Subject has idiopathic RP (patient may have undifferentiated connective tissue disease with positive ANA) diagnosed for more than two (2) years
* If a female, subject must be non-pregnant and non-lactating
* The subject has provided written informed consent prior to admission to this study
Exclusion Criteria
* History in the past five (5) years of drug or alcohol abuse
* History in the past five (5) years of vascular migraine or other chronic severe headache
* History in the past five (5) years of autonomic neuropathy or postural hypotension
* Unwilling or unable to comply with the restrictions outlined in the protocol
* Current use of smoking cessation treatment, including nicotine patches
* History of drug allergies, anaphylaxis or laryngeal oedema, including allergy to GTN, propylene/ethylene glycol or common moisturizing creams
* Use of any nitrate medication or any phosphodiesterase inhibitor within three (3) days prior to or intended use one (1) day following each dosing with study drug
* Currently treated for hypertension
* Currently receiving treatment for prevention and/or treatment of RP
* Use of any investigational medication within 30 days prior to dosing with study medication or scheduled to receive an investigational drug other than during the course of this study
* Open skin lesions or pathological condition (including, but not limited to, infection) in the area where the study medication is to be applied
* Use of topical corticosteroid to the hand or fingers within 10 days of treatment with study drug
* Withdrawal of consent at any time during the study
* Any condition, which compromises ability to give informed consent or to communicate with the investigator as required for the completion of this study
* Previously enrolled in the study
18 Years
50 Years
ALL
No
Sponsors
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Procris Pharmaceuticals
INDUSTRY
Responsible Party
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Procris Pharmaceuticals
Locations
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University of Iowa-Institute for Clinical and Translational Science
Iowa City, Iowa, United States
Countries
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Other Identifiers
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P150-005
Identifier Type: -
Identifier Source: org_study_id