Tadalafil for the Treatment of Raynaud's

NCT00822354 | Completed Results

• 1 other identifier: STU1199
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Raynaud

Keywords

Secondary Raynaud's Phenomenon

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Secondary Outcomes (2)

• Digital Blood Pressure

  9 weeks

• Capillary Diameter

  9 weeks

Study Arms (2)

1

EXPERIMENTAL

Subjects will receive tadalafil 20mg every other day for the first month, and then placebo for the second month.

Drug: Tadalafil

2

EXPERIMENTAL

Subjects will receive placebo for the first month, and tadalafil 20mg orally every other day for the second month.

Drug: Tadalafil

Interventions

Tadalafil DRUG

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

Also known as: Cialis

1; 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Maltez N, Maxwell LJ, Rirash F, Tanjong Ghogomu E, Harding SE, Tingey PC, Wells GA, Tugwell P, Pope J. Phosphodiesterase 5 inhibitors (PDE5i) for the treatment of Raynaud's phenomenon. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD014089. doi: 10.1002/14651858.CD014089.

  PMID: 37929840 DERIVED

MeSH Terms

Conditions

Raynaud Disease

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Clinical Trials Coordinator
• Organization: Northwestern University

j-bae@northwestern.edu

312-695-6829

Study Officials

• Anne Laumann, MBChB, MRCP

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology

Study Record Dates

• First Submitted: May 31, 2008
• First Posted: January 14, 2009
• Study Start: September 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: April 1, 2010
• Last Updated: December 4, 2014
• Results First Posted: December 4, 2014

Record last verified: 2014-12

Locations

US (1)