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

This study has been completed.
Sponsor:
Information provided by:
Procris Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00700518
First received: June 13, 2008
Last updated: December 29, 2008
Last verified: December 2008
  Purpose

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.


Condition Intervention Phase
Raynaud's Phenomenon
Drug: placebo cream
Drug: Glyceryl Trinitrate
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I Trial of the Pharmacodynamic Dose Response to Topical Trinitrate in Patients With Raynaud's Phenomenon

Resource links provided by NLM:


Further study details as provided by Procris Pharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate the dose proportionality of the microvascular response to topical Glyceryl Trinitrate [ Time Frame: 6 visits no less than 10 hours between visits ] [ Designated as safety issue: Yes ]
  • Compare the systemic versus topical effect of Glyceryl Trinitrate on vascular response. [ Time Frame: 6 visits no less than 10 hours between visits ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: June 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1.
placebo cream applied to 2 adjacent fingers on non-dominant hand one time
Drug: placebo cream
placebo cream applied to 2 adjacent fingers of non-dominant hand one time
Active Comparator: 2
0.6mg of Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand
Drug: Glyceryl Trinitrate
0.6mg of Glyceryl Trinitrate applied to 2 adjacent fingers on non-dominant hand one time
Active Comparator: 3
1.2mg of Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time
Drug: Glyceryl Trinitrate
1.2mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time
Active Comparator: 4
1.8mg Glyceryl Trinitrate topically to 2 adjacent fingers on non-dominant hand one time
Drug: Glyceryl Trinitrate
1.8mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time
Active Comparator: 5
2.4 mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time
Drug: Glyceryl Trinitrate
2.4 mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700518

Locations
United States, Iowa
University of Iowa-Institute for Clinical and Translational Science
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Procris Pharmaceuticals
  More Information

No publications provided

Responsible Party: Matthew A. Gonda, Ph.D, Procris Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00700518     History of Changes
Other Study ID Numbers: P150-005
Study First Received: June 13, 2008
Last Updated: December 29, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Procris Pharmaceuticals:
Raynaud's Syndrome
Raynaud's Disease
RP

Additional relevant MeSH terms:
Raynaud Disease
Cardiovascular Diseases
Peripheral Vascular Diseases
Vascular Diseases
Nitroglycerin
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 20, 2014