Tadalafil for the Treatment of Raynaud's
Information source: Northwestern University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Raynaud
Intervention: Tadalafil (Drug)
Phase: N/A
Status: Completed
Sponsored by: Northwestern University Official(s) and/or principal investigator(s): Anne Laumann, MBChB, MRCP, Principal Investigator, Affiliation: Northwestern University
Summary
The investigators propose that tadalafil will increase digital blood flow and improve the
symptoms and signs of secondary Raynaud's phenomenon.
Clinical Details
Official title: Tadalafil for the Treatment of Secondary Raynaud's Phenomenon
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Number of Raynaud's Phenomenon Attacks Per DayDuration of Raynaud's Phenomenon Attacks Raynaud Severity Visual Analog Score (VAS) Raynaud's Condition Score (RCS) Visual Analog Scale (VAS)
Secondary outcome: Digital Blood PressureCapillary Diameter
Detailed description:
The primary goal of our study is to decrease the frequency, duration and severity of
vasospastic attacks in patients with secondary Raynaud's. The secondary goal is to document
increased blood flow and lessened capillary dysfunction in these patients. Both of these
goals are to be achieved using a course of treatment with Tadalafil. We anticipate a decrease
in the frequency, duration and severity of Raynaud's attacks. Improved digital blood flow
and digital blood pressures, and a decrease in digital capillary dysfunction.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- active Raynaud's Phenomenon
- stable disease and medication requirements over the previous 2 months
- subjects willing and able to participate in study assessments
- ability to understand and sign informed consent
- ages 18 to 65, both sexes
- a diagnosis of diffuse or limited cutaneous sclerosis, MCTD using the American
College Rheumatology criteria
Exclusion Criteria:
- uncontrolled HTN, DM, unstable disease, angina or using oral nitrates
- smoking, active alcoholism, drug abuse within 5 years
- abnormal renal function
- ulnar arterial occlusive disease as shown by a positive Allen Test
- Pregnant or breast feeding or considering preg. in next 4 months
- past or present major psych. illness
- allergy or sensitivity to tadalafil
- subject unable to understand protocol or give informed consent
- part. in another study trial within 30 days
- taking sildenafil
Locations and Contacts
Northwestern University Feinberg School of Medicine, Department of Dermatology, Chicago, Illinois 60611, United States
Additional Information
Starting date: September 2008
Last updated: December 2, 2014
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