DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 Day

Duration of Raynaud's Phenomenon Attacks

Raynaud Severity Visual Analog Score (VAS)

Raynaud's Condition Score (RCS) Visual Analog Scale (VAS)

Secondary outcome:

Digital Blood Pressure

Capillary 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017