Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-02-25 @ 10:05 PM
Study NCT ID:
NCT02050360
Status:
COMPLETED
Last Update Posted:
2016-01-18
First Post:
2014-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"As Required" Oral Sildenafil in Raynaud's Phenomenon
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011928', 'term': 'Raynaud Disease'}, {'id': 'D012595', 'term': 'Scleroderma, Systemic'}], 'ancestors': [{'id': 'D000090122', 'term': 'Livedoid Vasculopathy'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068677', 'term': 'Sildenafil Citrate'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-15', 'studyFirstSubmitDate': '2014-01-28', 'studyFirstSubmitQcDate': '2014-01-29', 'lastUpdatePostDateStruct': {'date': '2016-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Mean change in the Raynaud's Condition Score (RCS) during treatment, as compared to placebo.", 'timeFrame': '7 days', 'description': 'RCS is self-reported every day and averaged over 7-day periods'}], 'secondaryOutcomes': [{'measure': 'Frequency of RP: number of RP attacks during treatment, as compared to placebo.', 'timeFrame': '7 days', 'description': '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'}, {'measure': "Patients' preference: comparison between the number of patients favoring a treatment to another.", 'timeFrame': 'Every 3 weeks of treatment (week 3, 6 and 9)'}, {'measure': "Pain associated with RP: Mean change in the Raynaud's pain score during treatment, as compared to placebo.", 'timeFrame': '7 days', 'description': 'Pain associated with each attack is self-reported on a 10-point scale, and averaged over 7-day periods'}, {'measure': 'Frequency and severity of adverse drug events during treatment, as compared to placebo', 'timeFrame': '7 days'}, {'measure': 'Microvascular reactivity: index of skin perfusion in response to local/regional cooling after a single dose of sildenafil, as compared to placebo (laboratory experiments)', 'timeFrame': 'Week 1, 2 and 3'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Raynaud's phenomenon", 'Sildenafil', 'Systemic Sclerosis', 'Local cooling', 'Microcirculation'], 'conditions': ["Raynaud's Phenomenon"]}, 'referencesModule': {'references': [{'pmid': '37929840', 'type': 'DERIVED', 'citation': "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."}, {'pmid': '30383134', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether "on-demand" sildenafil is effective in the treatment of Raynaud\'s phenomenon.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Active Raynaud's Phenomenon characterized by a clinical history of primary or secondary Raynaud's Phenomenon\n* At least 7 RP attacks per week on 5 or more days per week (assessed over the 2 weeks preceding inclusion)\n* Patients who have dated and signed the informed consent form\n* Contraception for women\n\nExclusion Criteria:\n\n* Recently diagnosed RP (less than 2 months).\n* Uncontrolled hypertension, diabetes mellitus, angina\n* Haemodynamic instability\n* Nonarteritic ischemic optic neuropathy\n* Pulmonary hypertension\n* Subjects currently taking sildenafil, tadalafil or vardenafil\n* Subjects currently taking nitrates\n* Subjects currently taking strong CYP3A inhibitors\n* Pregnancy (or considering pregnancy in the next 4 months)\n* Breast feeding\n* Participation in another clinical trial"}, 'identificationModule': {'nctId': 'NCT02050360', 'acronym': 'PROFIL', 'briefTitle': '"As Required" Oral Sildenafil in Raynaud\'s Phenomenon', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Efficacy and Safety of "as Required" Sildenafil for Patients With Moderate to Severe Raynaud\'s Phenomenon (RP)', 'orgStudyIdInfo': {'id': 'DCIC/12/26'}, 'secondaryIdInfos': [{'id': '2013-000014-38', 'type': 'EUDRACT_NUMBER'}, {'id': '12G01', 'type': 'OTHER', 'domain': 'Promotor'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sildenafil 80 mg', 'description': 'Sildenafil 80 mg', 'interventionNames': ['Drug: Sildenafil 80 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Sildenafil 40 mg', 'description': 'Sildenafil 40 mg', 'interventionNames': ['Drug: Sildenafil 40 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Sildenafil 40 mg', 'type': 'DRUG', 'armGroupLabels': ['Sildenafil 40 mg']}, {'name': 'Sildenafil 80 mg', 'type': 'DRUG', 'armGroupLabels': ['Sildenafil 80 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Grenoble', 'country': 'France', 'facility': 'Clinical Investigation Center - Pharmacology Unit - University Hospital of Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Jean-Luc CRACOWSKI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'INSERM CIC03 - Unité de Pharmacologie Clinique'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}