Xerostomia Clinical Trial
Official title:
Multicenter Controlled Parallel-Groups Trial to Evaluate the Efficacy, Safety and Acceptability of TGO Buccal Spray Versus a Saliva Substitute in the Treatment of Psychotropic Medicines-Induced Xerostomia
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.
Status | Completed |
Enrollment | 74 |
Est. completion date | April 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
France | Chu Hopital Des Broussailles | Cannes |
Lead Sponsor | Collaborator |
---|---|
Laboratoires CARILENE |
France,
Fox PC. Management of dry mouth. Dent Clin North Am. 1997 Oct;41(4):863-75. Review. — View Citation
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