Efficacy Study of PDE-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon
This study has been completed.
Sponsor:
Seoul National University Hospital
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
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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
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| 30 Patients were initially recruited, but an error occurred in obtaining informed consent and this one was withdrawn.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
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
| 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 ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| 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
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 |