Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2026-01-01 @ 3:37 PM
Study NCT ID:
NCT00350350
Status:
COMPLETED
Last Update Posted:
2012-04-23
First Post:
2006-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OGT Spray in the Management of Xerostomia in the Elderly
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-07', 'completionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-20', 'studyFirstSubmitDate': '2006-07-06', 'studyFirstSubmitQcDate': '2006-07-06', 'lastUpdatePostDateStruct': {'date': '2012-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['XEROSTOMIA', 'MOUTH DRYNESS', 'ELDERLY', 'ORAL LUBRICANT'], 'conditions': ['XEROSTOMIA']}, 'referencesModule': {'references': [{'pmid': '9344281', 'type': 'BACKGROUND', 'citation': 'Fox PC. Management of dry mouth. Dent Clin North Am. 1997 Oct;41(4):863-75.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the trial is to evaluate the efficacy, safety and clinical acceptability of OGT oromucosal spray in the relief of symptoms and signs of xerostomia in comparison with a saliva substitute (European Medical Device).', 'detailedDescription': 'Xerostomia is excessive dryness of the mouth. It is due to insufficient (hyposialism) or inexistent (asialia) saliva secretion.\n\nThere are many causes. Transitory xerostomia may occur in the presence of anxiety (stage fright, fear or dehydration). Prolonged xerostomia is most often related to a systemic disease, certain medicines or to radiotherapy of the head or neck.\n\nXerostomia is often accompanied by buccal symptoms and signs such as impaired sense of taste, fetid breath and mouth ulcers, and it disturbs functions such as speech, chewing and swallowing. Because of reduced salivary secretion, there is disturbance of the microbial colonization of the buccal cavity, increased demineralization and decreased remineralization of the teeth, impaired retention of dentures, dehydration of the mucosa and reduced lubrication of the buccal mucosa. These complications may take the form of dental caries, candidiasis, atrophy and feelings of burning of the mucosa, difficulty retaining dentures, impaired speech and swallowing and impression of decreased or impaired sense of taste. Xerostomia has significant harmful effects on the buccal cavity and on the quality of life of patients.\n\nXerostomia prevalence rates of the order of 18-61% have been reported in the elderly. These rates are generally higher in women that in men and increase with age. They are also higher in populations in institutions and in those taking multiple medications. Wearing a denture, stress and other psychological factors have also been suggested as factors increasing risk or or worsening xerostomia.\n\nTreatments of xerostomia are saliva substitutes and saliva stimulants.\n\nOGT Spray is neither a substitute nor stimulant of saliva.\n\nOGT Spray is a solution for oromucosal spray which has lubricant and protective actions.\n\nThe aim of the study was to demonstrate that OGT Spray (oral lubricant) was effective in the subjective relief of dry mouth symptoms and objective signs of dry mouth in elderly.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "elderly population at least 70 years old residents of old's people homes", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female, institutionalized and at least 70 years of age\n* with a diagnosis of xerostomia confirmed objectively by the saliva absorption test\n* having stopped all palliative treatment for xerostomia\n* legally capable of giving consent\n* capable and agreeing to participate in the study and capable and accepting to answer study questionnaires in accordance with the terms of the French Huriet Act on clinical trials,\n* remaining in the establishment throughout the study period\n\nExclusion Criteria:\n\n* Concomitant treatments incompatible with the trial, especially alcoholic solutions\n* buccal fungal infection\n* systemic infection or current dental care\n* current participation in other clinical trials\n* allergy or known intolerance to one of the constituents of the trial products\n* treatment with atropine\n* presence of active life-threatening disease'}, 'identificationModule': {'nctId': 'NCT00350350', 'briefTitle': 'OGT Spray in the Management of Xerostomia in the Elderly', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoires CARILENE'}, 'officialTitle': 'Multicenter, Controlled Parallel Groups Trial to Evaluate the Efficacy, Safety and Acceptability of OGT Oromucosal Spray Versus a Saliva Substitute in the Treatment of Xerostomia in Geriatrics', 'orgStudyIdInfo': {'id': 'CARILENE LABORATORY'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'elderly people', 'description': "elderly people over 70 years residents of old's people homes with symptoms of dry mouth", 'interventionNames': ['Device: oxygenated oil', 'Device: medical device. Spray containing essentially oxygenated oil']}], 'interventions': [{'name': 'oxygenated oil', 'type': 'DEVICE', 'otherNames': ['artificial saliva'], 'description': 'oxygenated oil in spray versus product reference (artificial saliva) dosage : one to two spray 5 times a day', 'armGroupLabels': ['elderly people']}, {'name': 'medical device. Spray containing essentially oxygenated oil', 'type': 'DEVICE', 'otherNames': ['artificial saliva'], 'description': 'protective oral spray containing :\n\n* 94.4% of oxygenated oil\n* Silicium dioxide\n* aspartame artificial flavoring', 'armGroupLabels': ['elderly people']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78200', 'city': 'Magnanville', 'state': 'Yvelines', 'country': 'France', 'facility': 'clinique Léopold Bellan', 'geoPoint': {'lat': 48.96798, 'lon': 1.67842}}], 'overallOfficials': [{'name': 'Michel MS SALOM, Gerontologis', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique Leopold Bellan 78200 Magnanville, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoires CARILENE', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eurofins Dermscan Pharmascan', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}