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

This study has been completed.
Sponsor:
Collaborator:
Dong-A Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Eun Bong Lee, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01280266
First received: January 14, 2011
Last updated: December 7, 2012
Last verified: December 2012
Results First Received: July 4, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Raynaud Phenomenon
Intervention: Drug: Udenafil or Amlodipine

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment begin Jan 13 2011 until Mar 15 2011. Location: Rheumatology outpatient clinic at Seoul National University Hospital, Seoul, Korea.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
30 Patients were initially recruited, but an error occurred in obtaining informed consent and this one was withdrawn.

Reporting Groups
  Description
Amlodipine-Udenafil (AU) Arm Amlodipine 10mg PO QD for 4 weeks, washout period for 1week, then Udenafil 100mg PO QD for 4 weeks.
Udenafil-Amlodipine (UA) Arm Udenafil 100mg PO QD for 4 weeks, washout period for 1 week, then Udenafil 10mg PO QD for 4 weeks.

Participant Flow for 3 periods

Period 1:   First Intervention (Week 1-4)
    Amlodipine-Udenafil (AU) Arm     Udenafil-Amlodipine (UA) Arm  
STARTED     15     14  
COMPLETED     14     12  
NOT COMPLETED     1     2  
Adverse Event                 1                 0  
Withdrawal by Subject                 0                 2  

Period 2:   Washout Period (Week 4-5)
    Amlodipine-Udenafil (AU) Arm     Udenafil-Amlodipine (UA) Arm  
STARTED     14     12  
COMPLETED     14     12  
NOT COMPLETED     0     0  

Period 3:   Second Intervention (Week 5-9)
    Amlodipine-Udenafil (AU) Arm     Udenafil-Amlodipine (UA) Arm  
STARTED     14     12  
COMPLETED     14     12  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Amlodipine-Udenafil (AU) Arm Amlodipine first, then Udenafil
Udenafil-Amlodipine (UA) Arm Udenafil first, then Amlodipine
Total Total of all reporting groups

Baseline Measures
    Amlodipine-Udenafil (AU) Arm     Udenafil-Amlodipine (UA) Arm     Total  
Number of Participants  
[units: participants]
  14     12     26  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     14     12     26  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  49.6  ± 14.0     52.3  ± 10.3     50.9  ± 12.3  
Gender  
[units: participants]
     
Female     13     11     24  
Male     1     1     2  
Region of Enrollment  
[units: participants]
     
Korea, Republic of     14     12     26  
Disease subtype [1]
[units: participant]
     
Localized systemic sclerosis (SSc)     1     2     3  
diffuse SSc     10     7     17  
Mixed connective tissue disease     1     2     3  
Sjogren's disease     2     1     3  
RP duration  
[units: years]
Mean ± Standard Deviation
  8.8  ± 8.7     5.6  ± 2.3     7.3  ± 6.6  
Prior use of vasodilator  
[units: Participant]
     
calcium channel blocker     1     4     5  
angiotensin receptor blocker     2     0     2  
Pentyxifylline     1     1     2  
No prior use     10     7     17  
[1] Underlying rheumatic disease



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   RP Attacks Per Day   [ Time Frame: baselin and 4 weeks ]

2.  Secondary:   Change in Raynaud's Condition Score (RCS)   [ Time Frame: baseline and 4 weeks ]

3.  Secondary:   Change in the RP Duration   [ Time Frame: baseline and 4 weeks ]

4.  Secondary:   Change in Health Assessment Questionnaire (HAQ)   [ Time Frame: 0 and 4 weeks ]

5.  Secondary:   Change in Physician's Global Assessment on Visual Analogue Scale (VAS)   [ Time Frame: at 0 (baseline) and 4 weeks (after treatment) ]

6.  Secondary:   Change in Digital Ulcer Number   [ Time Frame: baseline and 4 weeks ]

7.  Secondary:   Change in Peak Systolic Flow (cm/Sec)   [ Time Frame: baseline and 4 weeks ]

8.  Secondary:   Time-averaged Peak Velocity (cm/Sec)   [ Time Frame: baseline and 4 weeks ]

9.  Secondary:   Dorsal-digital-difference.   [ Time Frame: baseline and 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Eun Bong Lee
Organization: Seoul National University
phone: +82 2 2072-3944
e-mail: leb7616@snu.ac.kr


No publications provided


Responsible Party: Eun Bong Lee, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01280266     History of Changes
Other Study ID Numbers: RaynaudSNUH
Study First Received: January 14, 2011
Results First Received: July 4, 2012
Last Updated: December 7, 2012
Health Authority: Korea: Food and Drug Administration