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OGT Spray in the Management of Xerostomia in the Elderly

NCT00350350 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 74

Last updated 2012-04-23

No results posted yet for this study

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).

Conditions

  • XEROSTOMIA

Interventions

DEVICE

oxygenated oil

oxygenated oil in spray versus product reference (artificial saliva) dosage : one to two spray 5 times a day

DEVICE

medical device. Spray containing essentially oxygenated oil

protective oral spray containing : * 94.4% of oxygenated oil * Silicium dioxide * aspartame artificial flavoring

Sponsors & Collaborators

  • Eurofins Dermscan Pharmascan

    collaborator INDUSTRY

  • Laboratoires CARILENE

    lead INDUSTRY

Principal Investigators

  • Michel MS SALOM, Gerontologis · Clinique Leopold Bellan 78200 Magnanville, France

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2004-11-30
Completion
2004-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00350350 on ClinicalTrials.gov