Raynaud PhenomenonPhase 2/3NCT01280266
Efficacy Study of PDE-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon
A Phase 2/3 study testing Udenafil or Amlodipine in people with Raynaud Phenomenon, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Raynaud Phenomenon
- What is being tested?
- Udenafil or Amlodipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2011to Jun 2011
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- secondary Raynaud's phenomenon
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Raynaud Phenomenon
- Being tested
- Udenafil or Amlodipine
- Keywords
- Pathological Conditions, Signs and Symptoms, Blood circulation
- Medical subject headings
- Raynaud Disease, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Udenafil or AmlodipineDrug
Amlodipine 10mg daily then Udenafil 100 mg daily OR Udenafil 100 mg daily then Amlodipine 10mg daily
| Study group | Role | What they receive |
|---|---|---|
| Amlodipine-Udenafil (AU) arm | Experimental | Amlodipine 10mg PO QD for 4 weeks, washout period, then Udenafil 100mg PO QD for 4 weeks Receives: Drug: Udenafil or Amlodipine |
| Udenafil-Amlodipine (UA) arm | Experimental | Udenafil 100mg PO QD for 4 weeks, washout period, then Amlodipine 10mg PO QD for 4 weeks Receives: Drug: Udenafil or Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
RP Attacks Per Day
Change in RP frequency after amlodipine and udenafil number of RP attack per day 0 -- unlimited.
Measured: baselin and 4 weeks
Secondary outcomes (8)
Change in Raynaud's Condition Score (RCS)
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
Measured: baseline and 4 weeks
Change in the RP Duration
Change in the average RP duration in minutes (min) per attack. 0 -- unlimited
Measured: baseline and 4 weeks
Change in Health Assessment Questionnaire (HAQ)
Ordinal scale 0-10 0 good 10 bad
Measured: 0 and 4 weeks
Change in Physician's Global Assessment on Visual Analogue Scale (VAS)
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.
Measured: at 0 (baseline) and 4 weeks (after treatment)
Change in Digital Ulcer Number
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.
Measured: baseline and 4 weeks
Change in Peak Systolic Flow (cm/Sec)
Change in digital artery flow velocity in proper palmar digital artery in cm/sec.
0-unlimited
Measured: baseline and 4 weeks
Time-averaged Peak Velocity (cm/Sec)
changes in the averaged blood flow (Time-averaged peak velocity) Blood flow in cm/sec 0 - unlimited.
Measured: baseline and 4 weeks
Dorsal-digital-difference.
The temperature difference between finger tips and dorsum of same hand. range 0 - unlimited in degree celcius.
Measured: baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Raynaud PhenomenonStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dong-A Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Eun Bong Lee, Seoul National University Hospital
- Investigators
- Eun Bong Lee, MD PhD, Principal investigator, professor of Seoul National University College of MedicineEun Young Lee, MD PhD, Study director, Assistant professor, Seoul National University College of MedicineJin Kyun Park, MD, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280266
- Sponsor's protocol ID
- RaynaudSNUH
- Status last verified
- Dec 2012
- First submitted
- 14 Jan 2011
- Last updated
- 11 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
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.
PubMed 24352340
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Phosphodiesterase-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon, Double Blind, Randomized, Cross-over Trial
- ClinicalTrials.gov ID
- NCT01280266
- Acronym / sponsor ID
- RaynaudSNUH
- Conditions
- Raynaud Phenomenon
- Keywords
- Pathological Conditions, Signs and Symptoms, Blood circulation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Dong-A Pharmaceutical Co., Ltd.
- Study start
- Jan 2011
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 20 Jan 2011 (estimated)
- Results
- Posted 11 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amlodipine-Udenafil (AU) arm | Experimental | Drug: Udenafil or AmlodipineAmlodipine 10mg PO QD for 4 weeks, washout period, then Udenafil 100mg PO QD for 4 weeks |
| Udenafil-Amlodipine (UA) arm | Experimental | Drug: Udenafil or AmlodipineUdenafil 100mg PO QD for 4 weeks, washout period, then Amlodipine 10mg PO QD for 4 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- secondary Raynaud's phenomenon
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Udenafil or AmlodipineAmlodipine 10mg daily then Udenafil 100 mg daily OR Udenafil 100 mg daily then Amlodipine 10mg daily | Drug | Amlodipine-Udenafil (AU) arm, Udenafil-Amlodipine (UA) arm |
Primary outcome
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.
8 secondary outcomes
Change in Raynaud's Condition Score (RCS)
Time frame: baseline and 4 weeks
Change in the RP Duration
Time frame: baseline and 4 weeks
Change in Health Assessment Questionnaire (HAQ)
Time frame: 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)
Change in Digital Ulcer Number
Time frame: baseline and 4 weeks
Change in Peak Systolic Flow (cm/Sec)
Time frame: baseline and 4 weeks
Time-averaged Peak Velocity (cm/Sec)
Time frame: baseline and 4 weeks
Dorsal-digital-difference.
Time frame: baseline and 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24352340Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eun Bong Lee, MD PhD principal investigator
professor of Seoul National University College of Medicine
Eun Young Lee, MD PhD study director
Assistant professor, Seoul National University College of Medicine
Jin Kyun Park, MD study director
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Udenafil or Amlodipine in people with Raynaud Phenomenon, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RP Attacks Per Day (time frame: baselin and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01280266, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2012.