Ignite Creation Date:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2026-03-27 @ 7:30 PM
Study NCT ID:
NCT00982332
Status:
UNKNOWN
Last Update Posted:
2010-07-20
First Post:
2009-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Micro-Pulse Steroid Therapy as Induction Therapy in Patients With Polymyalgia Rheumatica
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011111', 'term': 'Polymyalgia Rheumatica'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001623', 'term': 'Betamethasone'}, {'id': 'C032812', 'term': 'betamethasone dipropionate, betamethasone sodium phosphate drug combination'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-07-18', 'studyFirstSubmitDate': '2009-09-15', 'studyFirstSubmitQcDate': '2009-09-22', 'lastUpdatePostDateStruct': {'date': '2010-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'a total dose of glucocorticoids used in the course of the disease', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['polymyalgia rheumatica'], 'conditions': ['Polymyalgia Rheumatica']}, 'descriptionModule': {'briefSummary': 'The study will examine the efficacy of a single intramuscular injection of betamethasone dipropionate/betamethasone sodium phosphate at the dose of 20mg/8mg (injection volume 4 ml) as an induction therapy in patients with polymyalgia rheumatica. Twenty patients will be randomized to receive an injection of betamethasone or placebo (isotonic NaCl solution) immediately after diagnosis. Both groups will receive the standard-of-care steroid therapy, starting from 10 mg of prednisone every day (qd), tapered down by 2.5 mg monthly if the disease is not active (scheduled monthly follow-ups by a rheumatologist). Primary outcome measures: the total cumulative dose of glucocorticosteroids and disease duration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of polymyalgia rheumatica\n\nExclusion Criteria:\n\n* decompensated diabetes mellitus\n* decompensated arterial hypertension'}, 'identificationModule': {'nctId': 'NCT00982332', 'briefTitle': 'Efficacy of Micro-Pulse Steroid Therapy as Induction Therapy in Patients With Polymyalgia Rheumatica', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bnai Zion Medical Center'}, 'officialTitle': 'Efficacy of Micro-pulse Steroid Therapy as Induction Therapy in Patients With Polymyalgia Rheumatica', 'orgStudyIdInfo': {'id': 'POLYMYALGIA1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'betamethasone', 'description': 'patients treated with a single intramuscular injection of betamethasone', 'interventionNames': ['Drug: Betamethasone', 'Drug: isotonic sodium chloride solution (placebo)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'isotonic sodium chloride solution', 'interventionNames': ['Drug: isotonic sodium chloride solution (placebo)']}], 'interventions': [{'name': 'Betamethasone', 'type': 'DRUG', 'otherNames': ['diprospan injection'], 'description': 'betamethasone dipropionate 20 mg + betamethasone sodium phosphate 8 md as a single intramuscular injection', 'armGroupLabels': ['betamethasone']}, {'name': 'isotonic sodium chloride solution (placebo)', 'type': 'DRUG', 'description': '4 ml intramuscular', 'armGroupLabels': ['betamethasone', 'isotonic sodium chloride solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38041', 'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Gleb Slobodin, MD', 'role': 'CONTACT', 'email': 'gleb.slobodin@b-zion.org.il', 'phone': '972-506267284'}, {'name': 'Doron Rimar, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gleb Slobodin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mona Elias, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michael Rozenbaum, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nina Boulman, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Itzhak Rosner, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Bnai Zion Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Gleb Slobodin, MD', 'role': 'CONTACT', 'email': 'gleb.slobodin@b-zion.org.il', 'phone': '972-506267284'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bnai Zion Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Gleb Slobodin MD', 'oldOrganization': 'Bnai Zion MC'}}}}