NCT02049112

Brief Summary

The purpose of this study is to evaluate the clinical efficacy, safety and acceptability of our new oral salivary equivalent in the relief of signs and symptoms related to mouth dryness as compared to two distinct moisturizing currently marketed oral sprays (Aequasyal® \& Biotene®) in patients with xerostomia due to chronic hyposalivation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2012

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

January 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 29, 2014

Completed
Last Updated

January 29, 2014

Status Verified

January 1, 2014

Enrollment Period

1.2 years

First QC Date

January 27, 2014

Last Update Submit

January 27, 2014

Conditions

XerostomiaHyposalivationHead and Neck CancerSjögren Syndrome

Keywords

Cross-overSalivary equivalentDry mouthMedical device

Outcome Measures

Primary Outcomes (1)

  • Dry mouth discomfort

    Patient evaluation through the completion of a self rated 100 mm long VAS score. Anchor points of the VAS score will be 0 representing the absence of any dry mouth symptoms and 100 representing the worst imaginable picture of dry mouth discomfort

    14 days

Secondary Outcomes (7)

  • Mouth burning sensation

    14 days

  • Speech difficulties

    14 days

  • Chewing difficulties

    14 days

  • Swallowing difficulties

    14 days

  • Taste perversion

    14 days

  • +2 more secondary outcomes

Study Arms (3)

Salivary equivalent

EXPERIMENTAL

Single dose stick without any active substance

Device: Salivary equivalent

Aequasyal

SHAM COMPARATOR

Multidose moisturizing oral spray without any active substance

Device: Aequasyal

Biotene

SHAM COMPARATOR

Multidose moisturizing oral spray without any active substance

Device: Biotene

Interventions

Salivary equivalentDEVICE

14-day treatment with salivary equivalent sticks

Salivary equivalent
AequasyalDEVICE

14-day treatment with Aequasyal oral spray

Aequasyal
BioteneDEVICE

14-day treatment with Biotene oral spray

Biotene

Eligibility Criteria

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

You may qualify if:

  • Patients:
  • Aged 18 years or more,
  • Clinical diagnosis of xerostomia by a severe reduction of salivation, as detected by patient's answers to few specific questions and measured by saliva volume at screening visit (test of saliva weight absorbed ≤ 0.1g/min)
  • Any medical condition or treatment leading to a severe reduction of salivation related to either:
  • Head and neck radiation therapy for cancer,
  • Gougerot-Sjögren syndrome
  • Medications known to induce xerostomia (psychotropic drugs, antihypertensive drugs)
  • Dehydration, hypothyroidism, Parkinson's disease and/or diabetes mellitus
  • Female patients must be post-menopausal or using a highly effective method for avoidance of pregnancy throughout the whole study duration, if childbearing potential.
  • Able to understand and comply with the protocol procedures
  • Willing and able to give their written informed consent
  • Affiliated to the French National Health Insurance Program

You may not qualify if:

  • Known hypersensitivity to one of the study products or to one of their components
  • Any planned change in dosing of all known medications inducing mouth dryness
  • Concomitant treatment for xerostomia symptoms without a scheduled 3 to 7-day withdrawal window
  • Oral candidiasis as diagnosed by a microbiological test obtained from an unstimulated whole saliva sample until 3-week period from disease release
  • Oral ulceration
  • Alcohol (\>2 glasses of wine/day), smoking (\>10 cigarettes/day), caffeine and/or theine intake (\>4 cups/day)
  • Patients unable to fill out the questionnaires or to comply with the study protocol
  • Dental infection
  • Patients participating to another clinical trial at the time of the study entry or within 30 days prior to study enrolment
  • Life-threatening condition at the time of the study
  • Pregnant or lactating women and women of childbearing potential refusing to use adequate contraception.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leopold Bellan Private Hospital

Magnanville, 78200, France

Location

MeSH Terms

Conditions

XerostomiaHead and Neck NeoplasmsSjogren's Syndrome

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic DiseasesNeoplasms by SiteNeoplasmsArthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Michel SALOM, Medical

    Leopold Bellan Fundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2014

First Posted

January 29, 2014

Study Start

January 1, 2012

Primary Completion

April 1, 2013

Study Completion

June 1, 2013

Last Updated

January 29, 2014

Record last verified: 2014-01

Locations

FR(1)