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

Primary Purpose

Raynaud's Phenomenon

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

placebo cream

Glyceryl Trinitrate

About this trial

This is an interventional treatment trial for Raynaud's Phenomenon focused on measuring Raynaud's Syndrome, Raynaud's Disease, RP

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Iowa-Institute for Clinical and Translational Science

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Arm Description

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

0.6mg of Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand

1.2mg of Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time

1.8mg Glyceryl Trinitrate topically to 2 adjacent fingers on non-dominant hand one time

2.4 mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time

Outcomes

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT00700518

First Posted

June 13, 2008

Last Updated

December 29, 2008

Sponsor

Procris Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00700518

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2008

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

November 2008 (Actual)

Study Completion Date

November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Procris Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Raynaud's Phenomenon

Keywords

Raynaud's Syndrome, Raynaud's Disease, RP

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

0.6mg of Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand

Arm Title

Arm Type

Active Comparator

Arm Description

1.2mg of Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time

Arm Title

Arm Type

Active Comparator

Arm Description

1.8mg Glyceryl Trinitrate topically to 2 adjacent fingers on non-dominant hand one time

Arm Title

Arm Type

Active Comparator

Arm Description

2.4 mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time

Intervention Type

Drug

Intervention Name(s)

placebo cream

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Glyceryl Trinitrate

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Glyceryl Trinitrate

Intervention Description

1.2mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time

Intervention Type

Drug

Intervention Name(s)

Glyceryl Trinitrate

Intervention Description

1.8mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time

Intervention Type

Drug

Intervention Name(s)

Glyceryl Trinitrate

Intervention Description

2.4 mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

Time Frame

6 visits no less than 10 hours between visits

Title

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

Time Frame

6 visits no less than 10 hours between visits

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

University of Iowa-Institute for Clinical and Translational Science

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

12. IPD Sharing Statement

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

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