Status:
COMPLETED
OGT Spray in the Management of Xerostomia in the Elderly
Lead Sponsor:
Laboratoires CARILENE
Collaborating Sponsors:
Eurofins Dermscan Pharmascan
Conditions:
XEROSTOMIA
Eligibility:
All Genders
70+ years
Brief Summary
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 ...
Detailed Description
Xerostomia is excessive dryness of the mouth. It is due to insufficient (hyposialism) or inexistent (asialia) saliva secretion. There are many causes. Transitory xerostomia may occur in the presence ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00350350
Start Date
October 1 2003
End Date
December 1 2004
Last Update
April 23 2012
Active Locations (1)
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1
clinique Léopold Bellan
Magnanville, Yvelines, France, 78200