N/A
N=10
Tadalafil for the Treatment of Raynaud's
Raynaud
Bottom Line
View on ClinicalTrials.gov: NCT00822354 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Number of Raynaud's Phenomenon Attacks Per Day — 2.4; 1.1; 2.0; 2.3 Raynaud's attacks per day
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tadalafil (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Raynaud's Phenomenon Attacks Per Day |
2.4; 1.1; 2.0; 2.3 | — |
| PRIMARY Duration of Raynaud's Phenomenon Attacks |
5.7; 11.4; 1.2; 14.2 | — |
| PRIMARY Raynaud Severity Visual Analog Score (VAS) |
39; 16.5; 51.5; 37 | — |
| PRIMARY Raynaud's Condition Score (RCS) Visual Analog Scale (VAS) |
38.5; 9; 35; 26 | — |
| SECONDARY Digital Blood Pressure |
97; 80; 84; 80 | — |
| SECONDARY Capillary Diameter |
9.3; 10; 10.7; 10 | — |
Summary
The investigators propose that tadalafil will increase digital blood flow and improve the symptoms and signs of secondary Raynaud's phenomenon.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00822354). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.