Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01280266
Recruitment Status : Completed
First Posted : January 20, 2011
Results First Posted : December 11, 2012
Last Update Posted : December 11, 2012
Sponsor:
Collaborator:
Dong-A Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Eun Bong Lee, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE January 14, 2011
First Posted Date  ICMJE January 20, 2011
Results First Submitted Date  ICMJE July 4, 2012
Results First Posted Date  ICMJE December 11, 2012
Last Update Posted Date December 11, 2012
Study Start Date  ICMJE January 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 19, 2011)
Frequency of raynaud phenomenon (RP) attacks [ Time Frame: during 4 weeks ]
change in number of RP/week during the fourth week of treatment compared to the number of RP/week at baseline
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2012)
  • 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
  • Change in the RP Duration [ Time Frame: baseline and 4 weeks ]
    Change in the average RP duration in minutes (min) per attack. 0 -- unlimited
  • Change in Health Assessment Questionnaire (HAQ) [ Time Frame: 0 and 4 weeks ]
    Ordinal scale 0-10 0 good 10 bad
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2011)
  • Change in Raynaud's Condition Score (RCS) [ Time Frame: during 4 weeks ]
    change in the RCS during the fourth week of treatment from baseline, comparing active drug to placebo
  • change in the total duration of RP/week [ Time Frame: during 4 weeks ]
    change in the total duration of RP/week during the fourth week of treatment compared to the total duration of RP/week at baseline
  • Change in Health Assessment Questionnaire (HAQ) [ Time Frame: 4weeks ]
  • change in physician's Visual Analog Scale (VAS) [ Time Frame: 4weeks ]
  • change in patient's VAS [ Time Frame: 4weeks ]
  • prevalence of digital ulcer comparing Udenafil to Calcium Channel Blocker (CCB) [ Time Frame: 4weeks ]
  • Improvement of digital ulcer comparing Udenafil to CCB [ Time Frame: 4 weeks ]
  • remission of digital ulcer comparing Udenafil to CCB [ Time Frame: 4 weeks ]
  • change in nailfold capillary microscopy finding [ Time Frame: 4 weeks ]
    change in nailfold capillary microscopy finding during the fourth week of treatment from baseline, comparing active drug to placebo
  • change of digital artery flow velocity [ Time Frame: 4weeks ]
    change of digital artery flow velocity during the fourth week of treatment from baseline, comparing active drug to placebo
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of PDE-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon
Official Title  ICMJE Comparison of Phosphodiesterase-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon, Double Blind, Randomized, Cross-over Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Raynaud Phenomenon
Intervention  ICMJE Drug: Udenafil or Amlodipine
Amlodipine 10mg daily then Udenafil 100 mg daily OR Udenafil 100 mg daily then Amlodipine 10mg daily
Study Arms  ICMJE
  • Experimental: Amlodipine-Udenafil (AU) arm
    Amlodipine 10mg PO QD for 4 weeks, washout period, then Udenafil 100mg PO QD for 4 weeks
    Intervention: Drug: Udenafil or Amlodipine
  • Experimental: Udenafil-Amlodipine (UA) arm
    Udenafil 100mg PO QD for 4 weeks, washout period, then Amlodipine 10mg PO QD for 4 weeks
    Intervention: Drug: Udenafil or Amlodipine
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 7, 2012)
29
Original Estimated Enrollment  ICMJE
 (submitted: January 19, 2011)
30
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01280266
Other Study ID Numbers  ICMJE RaynaudSNUH
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eun Bong Lee, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Dong-A Pharmaceutical Co., Ltd.
Investigators  ICMJE
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
Study Director: Jin Kyun Park, MD Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP