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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00350350 |
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Date of registration:
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06/07/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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OGT Spray in the Management of Xerostomia in the Elderly
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Scientific title:
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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 |
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Date of first enrolment:
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October 2003 |
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Target sample size:
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74 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00350350 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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Countries of recruitment
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France
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Contacts
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Name:
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Michel MS SALOM, Gerontologis |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clinique Leopold Bellan 78200 Magnanville, France |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- male or female, institutionalized and at least 70 years of age
- with a diagnosis of xerostomia confirmed objectively by the saliva absorption test
- having stopped all palliative treatment for xerostomia
- legally capable of giving consent
- 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,
- remaining in the establishment throughout the study period
Exclusion Criteria:
- Concomitant treatments incompatible with the trial, especially alcoholic solutions
- buccal fungal infection
- systemic infection or current dental care
- current participation in other clinical trials
- allergy or known intolerance to one of the constituents of the trial products
- treatment with atropine
- presence of active life-threatening disease
Age minimum:
70 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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XEROSTOMIA
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Intervention(s)
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Device: oxygenated oil
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Device: medical device. Spray containing essentially oxygenated oil
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Secondary ID(s)
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CARILENE LABORATORY
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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