Raynaud's PhenomenonPhase 2/3PROFILNCT02050360
"As Required" Oral Sildenafil in Raynaud's Phenomenon
A Phase 2/3 study testing Sildenafil 40 mg and Sildenafil 80 mg in people with Raynaud's Phenomenon, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The purpose of this study is to determine whether "on-demand" sildenafil is effective in the treatment of Raynaud's phenomenon. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Raynaud's Phenomenon
- What is being tested?
- Sildenafil 40 mg and Sildenafil 80 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to May 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active Raynaud's Phenomenon characterized by a clinical history of primary or secondary Raynaud's Phenomenon
- At least 7 RP attacks per week on 5 or more days per week (assessed over the 2 weeks preceding inclusion)
- Patients who have dated and signed the informed consent form
- Contraception for women
Who cannot join
- Recently diagnosed RP (less than 2 months).
- Uncontrolled hypertension, diabetes mellitus, angina
- Haemodynamic instability
- Nonarteritic ischemic optic neuropathy
- Pulmonary hypertension
- Subjects currently taking sildenafil, tadalafil or vardenafil
Show all 11Show fewer
- Subjects currently taking nitrates
- Subjects currently taking strong CYP3A inhibitors
- Pregnancy (or considering pregnancy in the next 4 months)
- Breast feeding
- Participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
France1 site
Clinical Investigation Center - Pharmacology Unit - University Hospital of Grenoble
Grenoble
About this study
Official title: Efficacy and Safety of "as Required" Sildenafil for Patients With Moderate to Severe Raynaud's Phenomenon (RP)
The purpose of this study is to determine whether "on-demand" sildenafil is effective in the treatment of Raynaud's phenomenon.
- Conditions
- Raynaud's Phenomenon
- Being tested
- Sildenafil 40 mg, Sildenafil 80 mg, Placebo
- Keywords
- Raynaud's phenomenon, Sildenafil, Systemic Sclerosis, Local cooling, Microcirculation
- Medical subject headings
- Raynaud Disease, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil 40 mgDrug
Sildenafil 80 mgDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil 80 mg | Experimental | Sildenafil 80 mg Receives: Drug: Sildenafil 80 mg |
| Sildenafil 40 mg | Experimental | Sildenafil 40 mg Receives: Drug: Sildenafil 40 mg |
| Placebo | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in the Raynaud's Condition Score (RCS) during treatment, as compared to placebo.
RCS is self-reported every day and averaged over 7-day periods
Measured: 7 days
Secondary outcomes (5)
Frequency of RP: number of RP attacks during treatment, as compared to placebo.
An attack is defined as an episode of pallor or cyanosis (with or without pain,tingling or numbness). The number of attacks is self-reported every day and averaged over 7-day periods
Measured: 7 days
Patients' preference: comparison between the number of patients favoring a treatment to another.
Measured: Every 3 weeks of treatment (week 3, 6 and 9)
Pain associated with RP: Mean change in the Raynaud's pain score during treatment, as compared to placebo.
Pain associated with each attack is self-reported on a 10-point scale, and averaged over 7-day periods
Measured: 7 days
Frequency and severity of adverse drug events during treatment, as compared to placebo
Measured: 7 days
Microvascular reactivity: index of skin perfusion in response to local/regional cooling after a single dose of sildenafil, as compared to placebo (laboratory experiments)
Measured: Week 1, 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Raynaud's PhenomenonStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Luc CRACOWSKI, MD, Principal investigator, INSERM CIC03 - Unité de Pharmacologie Clinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050360
- Sponsor's protocol ID
- DCIC/12/26
- Other IDs
- 2013-000014-38, 12G01
- Acronym
- PROFIL
- Status last verified
- Jan 2016
- First submitted
- 28 Jan 2014
- Last updated
- 18 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Maltez N, Maxwell LJ, Rirash F, Tanjong Ghogomu E, Harding SE, Tingey PC, Wells GA, Tugwell P, Pope J. Phosphodiesterase 5 inhibitors (PDE5i) for the treatment of Raynaud's phenomenon. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD014089. doi: 10.1002/14651858.CD014089.
PubMed 37929840Roustit M, Giai J, Gaget O, Khouri C, Mouhib M, Lotito A, Blaise S, Seinturier C, Subtil F, Paris A, Cracowski C, Imbert B, Carpentier P, Vohra S, Cracowski JL. On-Demand Sildenafil as a Treatment for Raynaud Phenomenon: A Series of n-of-1 Trials. Ann Intern Med. 2018 Nov 20;169(10):694-703. doi: 10.7326/M18-0517. Epub 2018 Oct 30.
PubMed 30383134
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of "as Required" Sildenafil for Patients With Moderate to Severe Raynaud's Phenomenon (RP)
- ClinicalTrials.gov ID
- NCT02050360
- Acronym / sponsor ID
- PROFIL / DCIC/12/26
- Conditions
- Raynaud's Phenomenon
- Keywords
- Raynaud's phenomenon, Sildenafil, Systemic Sclerosis, Local cooling, Microcirculation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 30 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether "on-demand" sildenafil is effective in the treatment of Raynaud's phenomenon.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sildenafil 80 mg | Experimental | Drug: Sildenafil 80 mgSildenafil 80 mg |
| Sildenafil 40 mg | Experimental | Drug: Sildenafil 40 mgSildenafil 40 mg |
| Placebo | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Active Raynaud's Phenomenon characterized by a clinical history of primary or secondary Raynaud's Phenomenon
- At least 7 RP attacks per week on 5 or more days per week (assessed over the 2 weeks preceding inclusion)
- Patients who have dated and signed the informed consent form
- Contraception for women
Key exclusion criteria (11 listed)
- Recently diagnosed RP (less than 2 months).
- Uncontrolled hypertension, diabetes mellitus, angina
- Haemodynamic instability
- Nonarteritic ischemic optic neuropathy
- Pulmonary hypertension
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 |
|---|---|---|
| Sildenafil 40 mg | Drug | Sildenafil 40 mg |
| Sildenafil 80 mg | Drug | Sildenafil 80 mg |
| Placebo | Drug | Placebo |
Primary outcome
Mean change in the Raynaud's Condition Score (RCS) during treatment, as compared to placebo.
Time frame: 7 days
RCS is self-reported every day and averaged over 7-day periods
5 secondary outcomes
Frequency of RP: number of RP attacks during treatment, as compared to placebo.
Time frame: 7 days
Patients' preference: comparison between the number of patients favoring a treatment to another.
Time frame: Every 3 weeks of treatment (week 3, 6 and 9)
Pain associated with RP: Mean change in the Raynaud's pain score during treatment, as compared to placebo.
Time frame: 7 days
Frequency and severity of adverse drug events during treatment, as compared to placebo
Time frame: 7 days
Microvascular reactivity: index of skin perfusion in response to local/regional cooling after a single dose of sildenafil, as compared to placebo (laboratory experiments)
Time frame: Week 1, 2 and 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2016.
- Derived from this study: PubMed 37929840Maltez N, Maxwell LJ, Rirash F, Tanjong Ghogomu E, Harding SE, Tingey PC, Wells GA, Tugwell P, Pope J. Phosphodiesterase 5 inhibitors (PDE5i) for the treatment of Raynaud's phenomenon. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD014089. doi: 10.1002/14651858.CD014089.
- Derived from this study: PubMed 30383134Roustit M, Giai J, Gaget O, Khouri C, Mouhib M, Lotito A, Blaise S, Seinturier C, Subtil F, Paris A, Cracowski C, Imbert B, Carpentier P, Vohra S, Cracowski JL. On-Demand Sildenafil as a Treatment for Raynaud Phenomenon: A Series of n-of-1 Trials. Ann Intern Med. 2018 Nov 20;169(10):694-703. doi: 10.7326/M18-0517. Epub 2018 Oct 30.
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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.
Jean-Luc CRACOWSKI, MD principal investigator
INSERM CIC03 - Unité de Pharmacologie Clinique
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 Sildenafil 40 mg and Sildenafil 80 mg in people with Raynaud's Phenomenon, run by University Hospital, Grenoble at 1 site in France.
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 4 inclusion and 11 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 18 Jan 2016. 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 France. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean change in the Raynaud's Condition Score (RCS) during treatment, as compared to placebo. (time frame: 7 days). 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 NCT02050360, which also lists 2 linked publications.
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 18 Jan 2016.