Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT00577304
Eligibility Criteria:
Inclusion Criteria:
* Outpatients ages 15 - 70.
* Patients with a diagnosis of Raynaud's phenomenon.
* Patients who agree to apply study medication to their fingers.
* Patients who are willing to stop current topical vasodilator therapies.
* Patients who agree not to start or change dosage of current oral vasodilator therapies.
* Patients who agree not to use any nitrate therapy while participating in this study.
* Negative pregnancy test in fertile women and agreement to use effective contraception throughout the study.
Exclusion Criteria:
* Patients who currently use nitrate medication or medications known to interact with nitroglycerin.
* Patients who have an allergy to nitroglycerin or common topical gel ingredients.
* Patients with a history of severe headaches.
* Patients with an unstable medical problem.
* Patients with cognitive or language difficulties that would impair their ability to complete assessment of pain instruments.
* Patients who have had a recent heart attack or other uncontrolled heart condition.
* Patients who have participated in an investigational drug study within four weeks of visit one.
* Patients who have clinically significant abnormal lab values.
* Patients who have had recent major abdominal, thoracic or vascular surgery.
* Patients with interfering skin conditions.
* Pregnant or nursing women or women unwilling to comply with contraceptive requirements.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
70 Years
Study:
NCT00577304
Study Brief:
Protocol Section:
NCT00577304