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Completed

NCT Number: NCT00700518

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

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.

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Key information

Conditions

Raynaud's Phenomenon Cardiovascular Diseases Embolism and Thrombosis Livedoid Vasculopathy Peripheral Vascular Diseases Raynaud Disease Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Thrombosis Vascular Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Iowa-Institute for Clinical and Translational Science

Iowa City, Iowa, 52242, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

placebo cream

Drug

placebo cream applied to 2 adjacent fingers of non-dominant hand one time

glyceryl trinitrate

Drug

0.6mg of Glyceryl Trinitrate applied to 2 adjacent fingers on non-dominant hand one time

Primary outcomes

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

    Time frame: 6 visits no less than 10 hours between visits

Secondary outcomes

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

    Time frame: 6 visits no less than 10 hours between visits

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

    Time frame: 6 visits no less than 10 hours between visits

Sponsors and collaborators

Lead sponsor

Procris Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 18, 2008
Registry last updated
Dec 30, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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