- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00332618
Efficacy Study of Oxygenated Glycerol Triesters to Treat Xerostomia
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Contacts and Locations
Study Locations
-
-
-
Cannes, France, 06000
- Chu Hopital Des Broussailles
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Study Director: YVES YT TILLET, Expertpharma, WHITE TILLET Consultants
- Principal Investigator: Jean Baptiste JO Orler, Psychiatrist, Chu Hopital Des Broussailles
Publications and helpful links
General Publications
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Laboratoires CARILENE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Xerostomia
-
Cathrine RahbekDanish Cancer Society; DLHM - Danish Society for Mouth and Throat Cancer; Danish...Active, not recruitingXerostomia Following Radiotherapy | Xerostomia Following in Neck Ore Head After CancersurgeryDenmark
-
Bedford Hospital NHS TrustUnknownXerostomia | Xerostomia Due to Radiotherapy | Xerostomia Due to Hyposecretion of Salivary Gland
-
Institute of Oncology LjubljanaUniversity Medical Centre Ljubljana; University of Ljubljana; Blood Transfusion...Not yet recruitingXerostomia Following RadiotherapySlovenia
-
Catholic University of the Sacred HeartSunstar Italiana SRL.CompletedXerostomia | Xerostomia Following RadiotherapyItaly
-
Qazvin University Of Medical SciencesImam Khomeini HospitalCompletedRadiation-Induced XerostomiaIran, Islamic Republic of
-
Laboratoires CARILENEDERMSCAN-PHARMASCAN GROUP in charge of data analysisCompleted
-
Institut de Terapia Regenerativa TissularUnknownXerostomia Due to RadiotherapySpain
-
MeiraGTx, LLCActive, not recruitingRadiation-induced XerostomiaUnited States, Canada
-
Thomas KuhntVerband Deutscher DruckkammerzentrenTerminatedRadiation-induced XerostomiaGermany
Clinical Trials on OXYGENATED GLYCEROL TRIESTERS
-
King's College LondonKing Saud UniversityActive, not recruitingQuality of Life | Gingival Diseases | Plaque, DentalSaudi Arabia
-
University of BolognaUnknownLiver Diseases | Kidney DiseasesItaly
-
Laboratoires CARILENEDERMSCAN-PHARMASCAN GROUP in charge of data analysisCompleted
-
University of ZurichCompleted
-
Matteo RavaioliCompletedLiver Diseases | Kidney DiseasesItaly
-
University of BolognaAzienda Ospedaliera Città della Salute e della Scienza di Torino; IRCCS Azienda... and other collaboratorsNot yet recruitingLiver Transplantation | Hepatocellular Carcinoma | Liver Cancer | Tumor Recurrence | Ex-vivo Hypothermic PerfusionItaly
-
Francisco Javier Martínez NogueraCompletedAntioxidative Stress | Lactate Blood Increase | Performance Enhancing Product Use | Change, Body Weight | Change, Body Temperature | Thermal Sensation DisordersSpain
-
University of PittsburghHorizon Pharma Ireland, Ltd., Dublin IrelandCompletedMedium-chain Acyl-CoA Dehydrogenase (MCAD) DeficiencyUnited States
-
University Medical Center GroningenUniversity of ZurichCompletedLiver Transplantation | Organ Preservation | Hypothermic Machine PerfusionSwitzerland, Netherlands
-
Ultragenyx Pharmaceutical IncCompletedGlucose Transporter Type 1 Deficiency Syndrome (Glut1 DS)United States, Spain, Australia, France, Israel, Italy, United Kingdom