Tadalafil for the Treatment of Raynaud's

Raynaud Clinical Trial

Official title:

Tadalafil for the Treatment of Secondary Raynaud's Phenomenon

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00822354
• Other study ID #: STU1199
• Status: Completed
• Phase: N/A
• First received: May 31, 2008
• Last updated: December 2, 2014
• Start date: September 2008
• Est. completion date: April 2010

Study information

• Verified date: December 2014
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The investigators propose that tadalafil will increase digital blood flow and improve the symptoms and signs of secondary Raynaud's phenomenon.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Raynaud

Intervention

Drug:
• Tadalafil
Subjects will be randomized to receive either tadalafil for the first month followed by placebo or placebo for the first month and followed by tadalafil

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine, Department of Dermatology	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Raynaud's Phenomenon Attacks Per Day	Subjects kept a daily record of the number of Raynaud's phenomenon attacks they experienced per day. Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.	9 weeks	No
Primary	Duration of Raynaud's Phenomenon Attacks	Subjects kept a daily record of the number of Raynaud's phenomenon attacks they experienced per day and the duration of each attack. Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.	9 weeks	No
Primary	Raynaud Severity Visual Analog Score (VAS)	The VAS is a 100 millimeter (mm) line where 0 mm (left boundary) represents Raynaud's disease of low severity, and 100 mm (right boundary) represents extremely severe Raynaud's disease. The subject makes a vertical mark on the VAS to indicate the severity of Raynaud's disease over the past two weeks. The Raynaud's severity score is the distance from the left boundary to the vertical mark in mm. Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.	9 weeks	No
Primary	Raynaud's Condition Score (RCS) Visual Analog Scale (VAS)	The VAS is a 100 millimeter (mm) line where 0 mm (left boundary) represents no difficulty with Raynaud's disease, and 100 mm (right boundary) represents extreme difficulty with Raynaud's disease. The subject makes a vertical mark on the VAS to indicate difficulty experienced that day with Raynaud's disease. The RCS is the distance from the left boundary to the vertical mark in mm. Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.	9 weeks	No
Secondary	Digital Blood Pressure	Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.	9 weeks	No
Secondary	Capillary Diameter	Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.	9 weeks	No