Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00332618
Status:
COMPLETED
Last Update Posted:
2006-06-07
First Post:
2006-05-31
Brief Title:
Efficacy Study of Oxygenated Glycerol Triesters to Treat Xerostomia
Sponsor:
Laboratoires CARILENE
Organization:
Laboratoires CARILENE
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2003-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor saliva stimulants Oxygenated Glycerol Triesters is neither a replacement for nor stimulant of saliva It is a lubricant and protective solution for endobuccal spray
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 andor saliva stimulants Oxygenated Glycerol Triesters is neither a replacement for nor stimulant of saliva It is a lubricant and protective solution for endobuccal spray
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None