XerostomiaNCT00332618
Efficacy Study of Oxygenated Glycerol Triesters to Treat Xerostomia
An observational study of Xerostomia, run by Laboratoires CARILENE at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Xerostomia
- What is being tested?
- OXYGENATED GLYCEROL TRIESTERS
- Type of treatment
- Medical device
- How many people
- 74 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2003to Apr 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Xerostomia
- Being tested
- OXYGENATED GLYCEROL TRIESTERS
- Keywords
- MULTICENTER, CONTROLLED, PARALLEL GROUPS
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OXYGENATED GLYCEROL TRIESTERSDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2006 (estimated)
- Study startSep 2003
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for XerostomiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 74 participants
Sponsor and investigators
- Lead sponsor
- Laboratoires CARILENE
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- YVES YT TILLET, Expertpharma, Study director, WHITE TILLET ConsultantsJean Baptiste JO Orler, Psychiatrist, Principal investigator, CHU HOPITAL DES BROUSSAILLES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00332618
- Sponsor's protocol ID
- Laboratoires CARILENE
- Status last verified
- Mar 2003
- First submitted
- 31 May 2006
- Last updated
- 7 Jun 2006
- Results posted
- No
Publications
Fox PC. Management of dry mouth. Dent Clin North Am. 1997 Oct;41(4):863-75.
PubMed 9344281
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00332618
- Acronym / sponsor ID
- Laboratoires CARILENE
- Conditions
- Xerostomia
- Keywords
- MULTICENTER, CONTROLLED, PARALLEL GROUPS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants
- Lead sponsor
- Laboratoires CARILENEIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Study completion
- Apr 2004
- First posted
- 1 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OXYGENATED GLYCEROL TRIESTERS | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2006.
- Background: PubMed 9344281Fox PC. Management of dry mouth. Dent Clin North Am. 1997 Oct;41(4):863-75.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YVES YT TILLET, Expertpharma study director
WHITE TILLET Consultants
Jean Baptiste JO Orler, Psychiatrist principal investigator
CHU HOPITAL DES BROUSSAILLES
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Xerostomia, run by Laboratoires CARILENE at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00332618, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2006.