Efficacy Study of PDE-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon

Phase 2

Completed

Conditions: Raynaud Phenomenon

Interventions: Drug: Udenafil or Amlodipine

Registration Number: NCT01280266

Lead Sponsor: Seoul National University Hospital

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 29

Inclusion Criteria

secondary Raynaud's phenomenon

Exclusion Criteria

primary raynaud phenomenon
active infection
hypersensitivity to PDE5 inhibitor or Calcium Chanel Blocker (CCB)
elevated AST/ALT (3 times above the upper normal limit)
severe renal failure
patients on nitrite or nitric oxide (NO) donor treatment
recent history of cerebrovascular accidents, acute myocardial infarction, or coronary artery bypass surgery
hypotension (less than 90/50 mmHg) or uncontrolled hypertension

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Amlodipine-Udenafil (AU) arm	Udenafil or Amlodipine	Amlodipine 10mg PO QD for 4 weeks, washout period, then Udenafil 100mg PO QD for 4 weeks
Udenafil-Amlodipine (UA) arm	Udenafil or Amlodipine	Udenafil 100mg PO QD for 4 weeks, washout period, then Amlodipine 10mg PO QD for 4 weeks

Primary Outcome Measures

Name	Time	Method
RP Attacks Per Day	baselin and 4 weeks	Change in RP frequency after amlodipine and udenafil number of RP attack per day 0 -- unlimited.

Secondary Outcome Measures

Name	Time	Method
Change in Peak Systolic Flow (cm/Sec)	baseline and 4 weeks	Change in digital artery flow velocity in proper palmar digital artery in cm/sec. 0-unlimited
Change in Raynaud's Condition Score (RCS)	baseline and 4 weeks	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
Change in the RP Duration	baseline and 4 weeks	Change in the average RP duration in minutes (min) per attack. 0 -- unlimited
Change in Health Assessment Questionnaire (HAQ)	0 and 4 weeks	Ordinal scale 0-10 0 good 10 bad
Change in Physician's Global Assessment on Visual Analogue Scale (VAS)	at 0 (baseline) and 4 weeks (after treatment)	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.
Change in Digital Ulcer Number	baseline and 4 weeks	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-averaged Peak Velocity (cm/Sec)	baseline and 4 weeks	changes in the averaged blood flow (Time-averaged peak velocity) Blood flow in cm/sec 0 - unlimited.
Dorsal-digital-difference.	baseline and 4 weeks	The temperature difference between finger tips and dorsum of same hand. range 0 - unlimited in degree celcius.