OGT Spray in the Management of Xerostomia in the Elderly
Multicenter, Controlled Parallel Groups Trial to Evaluate the Efficacy, Safety and Acceptability of OGT Oromucosal Spray Versus a Saliva Substitute in the Treatment of Xerostomia in Geriatrics
1 other identifier
observational
74
1 country
1
Brief Summary
The primary objective of the trial is to evaluate the efficacy, safety and clinical acceptability of OGT oromucosal spray in the relief of symptoms and signs of xerostomia in comparison with a saliva substitute (European Medical Device).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2003
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 6, 2006
CompletedFirst Posted
Study publicly available on registry
July 10, 2006
CompletedApril 23, 2012
July 1, 2006
1.1 years
July 6, 2006
April 20, 2012
Conditions
Keywords
Study Arms (1)
elderly people
elderly people over 70 years residents of old's people homes with symptoms of dry mouth
Interventions
oxygenated oil in spray versus product reference (artificial saliva) dosage : one to two spray 5 times a day
protective oral spray containing : * 94.4% of oxygenated oil * Silicium dioxide * aspartame artificial flavoring
Eligibility Criteria
elderly population at least 70 years old residents of old's people homes
You may qualify if:
- male or female, institutionalized and at least 70 years of age
- with a diagnosis of xerostomia confirmed objectively by the saliva absorption test
- having stopped all palliative treatment for xerostomia
- legally capable of giving consent
- capable and agreeing to participate in the study and capable and accepting to answer study questionnaires in accordance with the terms of the French Huriet Act on clinical trials,
- remaining in the establishment throughout the study period
You may not qualify if:
- Concomitant treatments incompatible with the trial, especially alcoholic solutions
- buccal fungal infection
- systemic infection or current dental care
- current participation in other clinical trials
- allergy or known intolerance to one of the constituents of the trial products
- treatment with atropine
- presence of active life-threatening disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laboratoires CARILENElead
- Eurofins Dermscan Pharmascancollaborator
Study Sites (1)
clinique Léopold Bellan
Magnanville, Yvelines, 78200, France
Related Publications (1)
Fox PC. Management of dry mouth. Dent Clin North Am. 1997 Oct;41(4):863-75.
PMID: 9344281BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michel MS SALOM, Gerontologis
Clinique Leopold Bellan 78200 Magnanville, France
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2006
First Posted
July 10, 2006
Study Start
October 1, 2003
Primary Completion
November 1, 2004
Study Completion
December 1, 2004
Last Updated
April 23, 2012
Record last verified: 2006-07