Clinical trial NCT01280266: Efficacy Study of PDE-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon
Official title: Comparison of Phosphodiesterase-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon, Double Blind, Randomized, Cross-over Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Raynaud Phenomenon
Keywords: Pathological Conditions
Signs and Symptoms
Blood circulation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Dong-A Pharmaceutical Co., Ltd.
First posted: 2011-01-20
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: RP Attacks Per Day
timeFrame: baselin and 4 weeks
Secondary outcomes:
measure: Change in Raynaud's Condition Score (RCS)
timeFrame: baseline and 4 weeks
measure: Change in the RP Duration
timeFrame: baseline and 4 weeks
measure: Change in Health Assessment Questionnaire (HAQ)
timeFrame: 0 and 4 weeks
measure: Change in Physician's Global Assessment on Visual Analogue Scale (VAS)
timeFrame: at 0 (baseline) and 4 weeks (after treatment)
measure: Change in Digital Ulcer Number
timeFrame: baseline and 4 weeks
measure: Change in Peak Systolic Flow (cm/Sec)
timeFrame: baseline and 4 weeks
measure: Time-averaged Peak Velocity (cm/Sec)
timeFrame: baseline and 4 weeks
measure: Dorsal-digital-difference.
timeFrame: baseline and 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: professor of Seoul National University College of Medicine
name: Eun Bong Lee, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant professor, Seoul National University College of Medicine
name: Eun Young Lee, MD PhD
role: STUDY_DIRECTOR
affiliation: Seoul National University Hospital
name: Jin Kyun Park, MD
role: STUDY_DIRECTOR
References:
citation: Lee EY, Park JK, Lee W, Kim YK, Park CS, Giles JT, Park JW, Shin K, Lee JS, Song YW, Lee EB. Head-to-head comparison of udenafil vs amlodipine in the treatment of secondary Raynaud's phenomenon: a double-blind, randomized, cross-over study. Rheumatology (Oxford). 2014 Apr;53(4):658-64. doi: 10.1093/rheumatology/ket417. Epub 2013 Dec 17.