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

Procris Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Raynaud's Phenomenon

Treatments: Drug: placebo cream; Drug: Glyceryl Trinitrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00700518

P150-005

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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10 participants in 5 patient groups, including a placebo group

1.

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo cream

2

Active Comparator group

Description:

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

Treatment:

Drug: Glyceryl Trinitrate

Drug: Glyceryl Trinitrate

Drug: Glyceryl Trinitrate

Drug: Glyceryl Trinitrate

3

Active Comparator group

Description:

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

Treatment:

Drug: Glyceryl Trinitrate

Drug: Glyceryl Trinitrate

Drug: Glyceryl Trinitrate

Drug: Glyceryl Trinitrate

4

Active Comparator group

Description:

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

Treatment:

Drug: Glyceryl Trinitrate

Drug: Glyceryl Trinitrate

Drug: Glyceryl Trinitrate

Drug: Glyceryl Trinitrate

5

Active Comparator group

Description:

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

Treatment:

Drug: Glyceryl Trinitrate

Drug: Glyceryl Trinitrate

Drug: Glyceryl Trinitrate

Drug: Glyceryl Trinitrate