The prevalence of Raynaud phenomenon (RP), a reversible vaso-constriction with skin discoloration, is 5-10% in general population. Often conventional measures such as warming up or minimizing exposure to cold are not enough and many patients require treatment with a vasodilator therapy. A recent study showed a good efficacy and safety profile of sildenafil, a selective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5) in RP. Here, the investigators aim to examine the efficacy and safety of Udenafil, a newer PDE5 inhibitor, as compared to amlodipine, a well known calcium channel blocker, in the treatment of secondary RP in Korean patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
29
Amlodipine 10mg daily then Udenafil 100 mg daily OR Udenafil 100 mg daily then Amlodipine 10mg daily
Seoul National University Hospital
Seoul, South Korea
RP Attacks Per Day
Change in RP frequency after amlodipine and udenafil number of RP attack per day 0 -- unlimited.
Time frame: baselin and 4 weeks
Change in Raynaud's Condition Score (RCS)
change in the RCS. RCS combines daily activty, frequency, duration and severity as well as impact of RP attack (Measuring disease activity and functional status in patients with scleroderma and Raynaud's phenomenon, Merkel et al,Arthritis Rheum. 2002 Sep;46(9):2410-20). Range 0-10 ordinal scale 0..good 10.. bad
Time frame: baseline and 4 weeks
Change in the RP Duration
Change in the average RP duration in minutes (min) per attack. 0 -- unlimited
Time frame: baseline and 4 weeks
Change in Health Assessment Questionnaire (HAQ)
Ordinal scale 0-10 0 good 10 bad
Time frame: 0 and 4 weeks
Change in Physician's Global Assessment on Visual Analogue Scale (VAS)
Physician's global assessment (PGA) on VAS assesses the overall condition of the patient. The scale ranges from 0 - 10, with 0 being good and 10 bad. As such, change in the GPA measures the change in the patient's condition from the baseline. negative value (decrease in value) means improvement.
Time frame: at 0 (baseline) and 4 weeks (after treatment)
Change in Digital Ulcer Number
0 - unlimited. Number of digital ulcers in all fingers are counted by the investigators and recorded at each visit. The number of ulcers in all fingers indirectly reflect the extent of critical ischemia. As such. the decrease in digital ulcer number reflects positive response to treatment (=better blood flow), whereas the increase ulcer numbers indicates worsening finger ischemia from baseline.
Time frame: baseline and 4 weeks
Change in Peak Systolic Flow (cm/Sec)
Change in digital artery flow velocity in proper palmar digital artery in cm/sec. 0-unlimited
Time frame: baseline and 4 weeks
Time-averaged Peak Velocity (cm/Sec)
changes in the averaged blood flow (Time-averaged peak velocity) Blood flow in cm/sec 0 - unlimited.
Time frame: baseline and 4 weeks
Dorsal-digital-difference.
The temperature difference between finger tips and dorsum of same hand. range 0 - unlimited in degree celcius.
Time frame: baseline and 4 weeks
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