Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT01316393
Status:
COMPLETED
Last Update Posted:
2011-11-09
First Post:
2011-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Mucoprotective Product on Xerostomia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014987', 'term': 'Xerostomia'}], 'ancestors': [{'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-08', 'studyFirstSubmitDate': '2011-03-15', 'studyFirstSubmitQcDate': '2011-03-15', 'lastUpdatePostDateStruct': {'date': '2011-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OHIP questionaire health impact profile', 'timeFrame': '7 days', 'description': 'Effect on oral health quality will be assessed after each treatment period'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['xerostomia, saliva, mucoprotection, oral health'], 'conditions': ['Xerostomia']}, 'descriptionModule': {'briefSummary': 'In the present study with a randomized, cross-over, blind, placebo controlled design, the effects of a salivary substitute product and a new mucoprotective product with similar mechanisms of action but with different composition and characteristics will be evaluated in cancer patients suffering from xerostomia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patient must be at least 18 years of age.\n2. The patient must have clinical symptoms of xerostomia (dry mouth) due to treatment of head and neck cancer\n3. The patient must understand and consent in writing to the procedure.\n\nExclusion Criteria:\n\n1. Do not meet the criterion for "dry mouth" regarding saliva secretion threshold values.\n2. Known allergy to ingredients in the products to be used in the trial and/or allergy to soy, peanuts, citrus fruit,Yerba Santa or methyl parabene\n3. Patients who are unable or unwilling to cooperate with study procedures.'}, 'identificationModule': {'nctId': 'NCT01316393', 'briefTitle': 'Effects of Mucoprotective Product on Xerostomia', 'nctIdAliases': ['NCT01288118'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Camurus AB'}, 'officialTitle': 'Clinical Evaluation of a Salivary Substitute and a Mucoprotective Product on Xerostomia in Head-and-neck Cancer Patients', 'orgStudyIdInfo': {'id': 'HS-10-404'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'XER2020', 'description': 'mucoprotective product', 'interventionNames': ['Other: XER2020']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Saliva Natura', 'description': 'salivary substitute', 'interventionNames': ['Other: XER2020']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'XER2020 placebo', 'interventionNames': ['Other: XER2020']}], 'interventions': [{'name': 'XER2020', 'type': 'OTHER', 'description': 'mucoprotective product', 'armGroupLabels': ['Saliva Natura', 'XER2020', 'XER2020 placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-21421', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'Department of Prosthetic Dentistry, Malmö University', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Camurus AB', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Liselott Lindh, Principal Investigator, Prosthetic Dentistry, Malmö University, Malmö, Sweden', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}