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

June 13, 2008
December 29, 2008
June 2008
November 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00700518 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Dose Response to Topical Glyceryl Trinitrate in Patients With Raynaud's Phenomenon
A Phase I Trial of the Pharmacodynamic Dose Response to Topical 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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Raynaud's Phenomenon
  • Drug: placebo cream
    placebo cream applied to 2 adjacent fingers of non-dominant hand one time
  • Drug: Glyceryl Trinitrate
    0.6mg of Glyceryl Trinitrate applied to 2 adjacent fingers on non-dominant hand one time
  • Drug: Glyceryl Trinitrate
    1.2mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time
  • Drug: Glyceryl Trinitrate
    1.8mg 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
  • Placebo Comparator: 1.
    placebo cream applied to 2 adjacent fingers on non-dominant hand one time
    Intervention: Drug: placebo cream
  • Active Comparator: 2
    0.6mg of Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand
    Intervention: Drug: Glyceryl Trinitrate
  • Active Comparator: 3
    1.2mg of Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time
    Intervention: Drug: Glyceryl Trinitrate
  • Active Comparator: 4
    1.8mg Glyceryl Trinitrate topically to 2 adjacent fingers on non-dominant hand one time
    Intervention: Drug: Glyceryl Trinitrate
  • Active Comparator: 5
    2.4 mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time
    Intervention: Drug: Glyceryl Trinitrate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
November 2008
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00700518
P150-005
No
Matthew A. Gonda, Ph.D, Procris Pharmaceuticals
Procris Pharmaceuticals
Not Provided
Not Provided
Procris Pharmaceuticals
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP