Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2025-12-25 @ 10:42 PM
Study NCT ID:
NCT01426295
Status:
COMPLETED
Last Update Posted:
2016-05-03
First Post:
2011-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmaco-economic Study of a New Medical Device Performed From the Perspective of the Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006402', 'term': 'Hematologic Diseases'}], 'ancestors': [{'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-02', 'studyFirstSubmitDate': '2011-08-26', 'studyFirstSubmitQcDate': '2011-08-30', 'lastUpdatePostDateStruct': {'date': '2016-05-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assess the cost-effectiveness ratio is the number of days with severe mucositis won.', 'timeFrame': 'up to 28 days'}], 'secondaryOutcomes': [{'measure': 'The number of days without medication morphine won', 'timeFrame': 'up to 28 days'}, {'measure': 'Aggregate saving medicines prescribed Supportive', 'timeFrame': 'up to 28 days'}, {'measure': 'The incidence of mucositis', 'timeFrame': 'up to 28 days'}, {'measure': 'The intensity of pain assessed with a visual analogue scale', 'timeFrame': 'up to 28 days'}, {'measure': 'The cumulative dose of morphine administered and the number of days of treatment,', 'timeFrame': '28 days'}, {'measure': 'The duration of febrile neutropenia', 'timeFrame': 'up to 28 days'}, {'measure': '- The incidence and duration of treatment of anti-infective and antifungal', 'timeFrame': '28 jours'}, {'measure': 'The incidence of total parenteral nutrition', 'timeFrame': 'up to 28 days'}, {'measure': '- The duration of Release aplasia (ANC> 500/mm3),', 'timeFrame': 'up to 28 days'}, {'measure': 'The duration of the hospitalization', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 28 days'}, {'measure': 'The severity of mucositis', 'timeFrame': 'up to 28 days'}, {'measure': 'The duration of pain assessed with a visual analogue scale,', 'timeFrame': 'up to 28 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hematologic disease candidates for autologous or allogeneic bone marrow'], 'conditions': ['Hematologic Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether the use of mouthwashes Caphosol ™ in addition to standard oral care (strategy A) is cost-effective in the prevention and treatment of severe mucositis in adult patients with auto or allograft packaging without ICT versus mouthwashes standard bicarbonates with an antiseptic (strategy B).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\> 18 years\n\nPatient receiving:\n\n* Conditioning of autologous bone marrow transplantation by high dose melphalan (HD) as part of the management of myeloma or BEAM in lymphoma.\n* A conditioning allogeneic bone marrow transplantation with reduced or intermediate busulfan IV\n* Patients belong to a schema of social security, having signed the written informed consent.\n\nExclusion Criteria:\n\n* patients:\n* To receive or have received KGF\n* With previous history of RT with the exception of patients who received spinal analgesic therapy in the treatment of myeloma\n* Unable or unwilling to complete the self assessment questionnaire\n* With previous history of allergy to any component of the products under consideration\n* Minor\n* Adults under guardianship\n* Pregnant women\n* Patients who have not signed the consent form\n* Creation of mouthwash out of the study'}, 'identificationModule': {'nctId': 'NCT01426295', 'acronym': 'Caphosol', 'briefTitle': 'Pharmaco-economic Study of a New Medical Device Performed From the Perspective of the Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Pharmaco-economic Cost-effective Prospective Randomized Trial Evaluating the Open Interest Caphosol ® Mouthwashes in the Prevention and Treatment of Severe Oral Mucositis in Patients Receiving High-dose Chemotherapy in Hematology', 'orgStudyIdInfo': {'id': 'BRD/10/06-C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Caphosol', 'interventionNames': ['Device: Caphosol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Référence', 'description': '•Bicarbonate de sodium à 1.4% Biosedra Versylène® or PAROEX® :', 'interventionNames': ['Drug: Bicarbonate de sodium']}], 'interventions': [{'name': 'Caphosol', 'type': 'DEVICE', 'description': 'The Caphosol ™ is a recently launched medical in France (2009). (source: laboratory EUSA Pharma ®)\n\nThe product is an aqueous solution for mouthwash that comes in the form of a hyper-saturated mixture of calcium phosphate at neutral pH to reconstitute immediately before use.\n\nEach patient randomized to the treatment arms in the study will receive daily at least 4 (maximum 10) mouthwash Caphosol ™.\n\nThe treatments are to begin preventive J1 to chemotherapy and continued until out of aplasia (ANC\\> 500/mm3), and / or mucositis grade 0.', 'armGroupLabels': ['Caphosol']}, {'name': 'Bicarbonate de sodium', 'type': 'DRUG', 'description': 'Treatment of the early start on the day of conditioning and stop when the ANC\\> 500/mm3 and / or mucositis grade zero, provisional date of bone exceeded.\n\nVersylène: Method of administration: gargle made with a minute from 15 to 30 mL, 2-5 times a day, alternating with PAROEX ®.', 'armGroupLabels': ['Référence']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44200', 'city': 'Nantes', 'country': 'France', 'facility': 'Nantes Universty Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'overallOfficials': [{'name': 'Thomas Gastinne, M D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jazz Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}