A New Oral salIvary equivAlent Compared to Two moisturizinG Mouth sprAys in Patients With xeRostomiA: NIAGARA Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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National, multicentre, randomised, active controlled, crossover, open-label study using a 3-latin-square design.

200 evaluable patients have been recruited

Conditions

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Xerostomia Hyposalivation Head and Neck Cancer Sjögren Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Salivary equivalent

Single dose stick without any active substance

Group Type EXPERIMENTAL

Salivary equivalent

Intervention Type DEVICE

14-day treatment with salivary equivalent sticks

Aequasyal

Multidose moisturizing oral spray without any active substance

Group Type SHAM_COMPARATOR

Aequasyal

Intervention Type DEVICE

14-day treatment with Aequasyal oral spray

Biotene

Multidose moisturizing oral spray without any active substance

Group Type SHAM_COMPARATOR

Biotene

Intervention Type DEVICE

14-day treatment with Biotene oral spray

Interventions

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Salivary equivalent

14-day treatment with salivary equivalent sticks

Intervention Type DEVICE

Aequasyal

14-day treatment with Aequasyal oral spray

Intervention Type DEVICE

Biotene

14-day treatment with Biotene oral spray

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No