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

Raynaud Phenomenon Clinical Trial

Official title:

Comparison of Phosphodiesterase-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon, Double Blind, Randomized, Cross-over Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01280266
• Other study ID #: RaynaudSNUH
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 14, 2011
• Last updated: December 7, 2012
• Start date: January 2011
• Est. completion date: June 2011

Study information

• Verified date: December 2012
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Raynaud Disease
• Raynaud Phenomenon

Intervention

Drug:
• Udenafil or Amlodipine
Amlodipine 10mg daily then Udenafil 100 mg daily OR Udenafil 100 mg daily then Amlodipine 10mg daily

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Dong-A Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RP Attacks Per Day	Change in RP frequency after amlodipine and udenafil number of RP attack per day 0 -- unlimited.	baselin and 4 weeks	No
Secondary	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	baseline and 4 weeks	No
Secondary	Change in the RP Duration	Change in the average RP duration in minutes (min) per attack. 0 -- unlimited	baseline and 4 weeks	No
Secondary	Change in Health Assessment Questionnaire (HAQ)	Ordinal scale 0-10 0 good 10 bad	0 and 4 weeks	No
Secondary	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.	at 0 (baseline) and 4 weeks (after treatment)	No
Secondary	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.	baseline and 4 weeks	No
Secondary	Change in Peak Systolic Flow (cm/Sec)	Change in digital artery flow velocity in proper palmar digital artery in cm/sec.; 0-unlimited	baseline and 4 weeks	No
Secondary	Time-averaged Peak Velocity (cm/Sec)	changes in the averaged blood flow (Time-averaged peak velocity) Blood flow in cm/sec 0 - unlimited.	baseline and 4 weeks	No
Secondary	Dorsal-digital-difference.	The temperature difference between finger tips and dorsum of same hand. range 0 - unlimited in degree celcius.	baseline and 4 weeks	No