NCT00332618

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2003

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 1, 2006

Completed
Last Updated

June 7, 2006

Status Verified

March 1, 2003

First QC Date

May 31, 2006

Last Update Submit

June 6, 2006

Conditions

Xerostomia

Keywords

MULTICENTERCONTROLLEDPARALLEL GROUPS

Interventions

OXYGENATED GLYCEROL TRIESTERSDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Hopital Des Broussailles

Cannes, 06000, France

Location

Related Publications (1)

  • Fox PC. Management of dry mouth. Dent Clin North Am. 1997 Oct;41(4):863-75.

    PMID: 9344281BACKGROUND

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • YVES YT TILLET, Expertpharma

    WHITE TILLET Consultants

    STUDY DIRECTOR

  • Jean Baptiste JO Orler, Psychiatrist

    CHU HOPITAL DES BROUSSAILLES

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 31, 2006

First Posted

June 1, 2006

Study Start

September 1, 2003

Study Completion

April 1, 2004

Last Updated

June 7, 2006

Record last verified: 2003-03

Locations

FR(1)