Clinical trial NCT00332618: Efficacy Study of Oxygenated Glycerol Triesters to Treat Xerostomia
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Xerostomia
Keywords: MULTICENTER
CONTROLLED
PARALLEL GROUPS
Lead sponsor: Laboratoires CARILENE
Sponsor class: INDUSTRY
First posted: 2006-06-01
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

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 dehydration). Prolonged xerostomia is most often related to a systemic disease, certain medicines or to radiotherapy of the head or neck.

Salivation depends upon the autonomic (sympathetic and parasympathetic) nervous system for its production and on the central nervous system for stimuli-dependant excretion. Substances acting on alpha an beta sympathetic receptors, whether agonists or antagonists, may induce hyposialia. Atropine, the main antagonist of the parasympathetic system, is present in many medicines used for pulmonary, ophthalmic or neurological purposes, potentially causing hyposialia. Similarly, imipramine antidepressants, phenothiazine neuroleptics, antihistamines and disopyramide predispose to the onset of hyposialia.

Xerostomia is often accompanied by buccal signs such as impaired sense of taste, halitosis and buccal ulcers and interferes with functions such as speech, chewing and swallowing. Because of reduced salivary secretion , there is a disturbance of the microbial colonization of the buccal cavity. Xerostomia has significant untoward effects on the buccal cavity and the quality of life of patients.

The basis of the treatment of xerostomia involves the use of saliva substitutes and/or saliva stimulants. Oxygenated Glycerol Triesters is neither a replacement for nor stimulant of saliva. It is a lubricant and protective solution for endobuccal spray.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cannes
country: France
facility: Chu Hopital Des Broussailles
Study officials:
affiliation: WHITE TILLET Consultants
name: YVES YT TILLET, Expertpharma
role: STUDY_DIRECTOR
affiliation: CHU HOPITAL DES BROUSSAILLES
name: Jean Baptiste JO Orler, Psychiatrist
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fox PC. Management of dry mouth. Dent Clin North Am. 1997 Oct;41(4):863-75.