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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000014-38 | EudraCT Number | ||
| 12G01 | Other Identifier | Promotor |
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The purpose of this study is to determine whether "on-demand" sildenafil is effective in the treatment of Raynaud's phenomenon.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sildenafil 80 mg | Experimental | Sildenafil 80 mg |
|
| Sildenafil 40 mg | Experimental | Sildenafil 40 mg |
|
| Placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sildenafil 40 mg | Drug |
| ||
| Sildenafil 80 mg |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 7 days |
| Patients' preference: comparison between the number of patients favoring a treatment to another. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Luc CRACOWSKI, MD | INSERM CIC03 - Unité de Pharmacologie Clinique | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Investigation Center - Pharmacology Unit - University Hospital of Grenoble | Grenoble | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37929840 | Derived | 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. | |
| 30383134 | Derived | Roustit 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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| ID | Term |
|---|---|
| D011928 | Raynaud Disease |
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D000090122 | Livedoid Vasculopathy |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Placebo | Drug |
|
| 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 | 7 days |
| Frequency and severity of adverse drug events during treatment, as compared to placebo | 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) | Week 1, 2 and 3 |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003240 | Connective Tissue Diseases |
| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |