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Dose Response to Topical Glyceryl Trinitrate in Patients With Raynaud's Phenomenon

Information source: Procris Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Raynaud's Phenomenon

Intervention: placebo cream (Drug); Glyceryl Trinitrate (Drug); Glyceryl Trinitrate (Drug); Glyceryl Trinitrate (Drug); Glyceryl Trinitrate (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Procris Pharmaceuticals


The purpose of this study is to evaluate the blood flow response to topical Glyceryl Trinitrate when applied to the skin of patient's fingers with Raynaud's Phenomenon.

Clinical Details

Official title: A Phase I Trial of the Pharmacodynamic Dose Response to Topical Trinitrate in Patients With Raynaud's Phenomenon

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Investigate vascular responses to topical Glyceryl Trinitrate versus placebo in patients with Raynaud's using laser Doppler imaging to measure blood flow

Secondary outcome:

Evaluate the dose proportionality of the microvascular response to topical Glyceryl Trinitrate

Compare the systemic versus topical effect of Glyceryl Trinitrate on vascular response.


Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.


Inclusion Criteria:

- Male and female volunteers aged between 18 and 50 inclusive

- 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 of clinically relevant medical illnesses (not considering RP) that in the

Investigator's opinion may jeopardize subject's safety or interfere with participation in the study, including but not limited to hemoglobinopathy, hemophilia, clinically significant retinal abnormalities, unstable hypertension, liver diseases, chronic pulmonary diseases, significant cardiovascular diseases, diabetes, thyroid diseases, gout, psychiatric or psychological disorders, CNS trauma or active seizure disorders, allergic or immunologically mediated disorders

- 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


- 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

Locations and Contacts

University of Iowa-Institute for Clinical and Translational Science, Iowa City, Iowa 52242, United States
Additional Information

Starting date: June 2008
Last updated: December 29, 2008

Page last updated: August 23, 2015

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