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

December 7, 2012 updated by: Eun Bong Lee, Seoul National University Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amlodipine-Udenafil (AU) arm
Amlodipine 10mg PO QD for 4 weeks, washout period, then Udenafil 100mg PO QD for 4 weeks
Drug: Udenafil or Amlodipine
Amlodipine 10mg daily then Udenafil 100 mg daily OR Udenafil 100 mg daily then Amlodipine 10mg daily
Experimental: Udenafil-Amlodipine (UA) arm
Udenafil 100mg PO QD for 4 weeks, washout period, then Amlodipine 10mg PO QD for 4 weeks
Drug: Udenafil or Amlodipine
Amlodipine 10mg daily then Udenafil 100 mg daily OR Udenafil 100 mg daily then Amlodipine 10mg daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RP Attacks Per Day
Time Frame: baselin and 4 weeks
Change in RP frequency after amlodipine and udenafil number of RP attack per day 0 -- unlimited.
baselin and 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Raynaud's Condition Score (RCS)
Time Frame: 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
baseline and 4 weeks
Change in the RP Duration
Time Frame: baseline and 4 weeks
Change in the average RP duration in minutes (min) per attack. 0 -- unlimited
baseline and 4 weeks
Change in Health Assessment Questionnaire (HAQ)
Time Frame: 0 and 4 weeks
Ordinal scale 0-10 0 good 10 bad
0 and 4 weeks
Change in Physician's Global Assessment on Visual Analogue Scale (VAS)
Time Frame: 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.
at 0 (baseline) and 4 weeks (after treatment)
Change in Digital Ulcer Number
Time Frame: 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.
baseline and 4 weeks
Change in Peak Systolic Flow (cm/Sec)
Time Frame: baseline and 4 weeks

Change in digital artery flow velocity in proper palmar digital artery in cm/sec.

0-unlimited
baseline and 4 weeks
Time-averaged Peak Velocity (cm/Sec)
Time Frame: baseline and 4 weeks
changes in the averaged blood flow (Time-averaged peak velocity) Blood flow in cm/sec 0 - unlimited.
baseline and 4 weeks
Dorsal-digital-difference.
Time Frame: baseline and 4 weeks
The temperature difference between finger tips and dorsum of same hand. range 0 - unlimited in degree celcius.
baseline and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Dong-A Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Eun Bong Lee, MD PhD, professor of Seoul National University College of Medicine
  • Study Director: Eun Young Lee, MD PhD, Assistant professor, Seoul National University College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

January 14, 2011

First Submitted That Met QC Criteria

January 19, 2011

First Posted (Estimate)

January 20, 2011

Study Record Updates

Last Update Posted (Estimate)

December 11, 2012

Last Update Submitted That Met QC Criteria

December 7, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RaynaudSNUH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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