Status:
COMPLETED
Efficacy Study of Oxygenated Glycerol Triesters to Treat Xerostomia
Lead Sponsor:
Laboratoires CARILENE
Conditions:
Xerostomia
Eligibility:
All Genders
18+ years
Brief Summary
The objective of the trial was to evaluate the efficacy and clinical safety and acceptability of Oxygenated Glycerol Triesters in the relief of symptoms of xerostomia versus a reference comparator.
Detailed Description
Xerostomia is due to inadequate (hyposialia) or inexistent (asialia) saliva secretion. There are may causes. Transitory xerostomia may occur in the presence of anxiety (stage fright, fear or dehydrat...
Eligibility Criteria
Inclusion
- men or women over 18 years of age
- with a diagnosis requiring the prescription of psychotropies (antidepressants, tranquilizers, etc) for more than 6 weeks
- having received no palliative treatment for xerostomia for a minimum of the past 2 weeks
- having xerostomia meeting the questionnaire selection criteria and the sialometer method parameters
- patients legally competent to give their consent
- capable of and accepting to participate in the trial and capable of and accepting to answer trial questionnaires
Exclusion
- combined treatments incompatible with the trial, un particular alcoholic solutions
- diabetes, any buccal condition requiring antimicrobial treatment
- Sjögren's syndrome or othermedical causes of xerostomia
- current participation in other clinical trials
- patient suffering from cancer
- patients with allergy to or known intolerance of any of the constituents of the investigational products
- patients treated with pilocarpine
Key Trial Info
Start Date :
September 1 2003
Trial Type :
OBSERVATIONAL
End Date :
April 1 2004
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00332618
Start Date
September 1 2003
End Date
April 1 2004
Last Update
June 7 2006
Active Locations (1)
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1
Chu Hopital Des Broussailles
Cannes, France, 06000