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

Study Overview
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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.

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

Official Title
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Phase 4 Study Evaluating Efficacy, Safety and Acceptability of Treatment With a New Salivary Equivalent Compared to Two Moisturizing Mouth Sprays on the Improvement of Dry Mouth Symptoms and Oral Comfort in Patients With Xerostomia.

Conditions
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Xerostomia, Hyposalivation, Head and Neck Cancer, Sjögren Syndrome

Intervention / Treatment
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* Device: Salivary equivalent
* Device: Aequasyal
* Device: Biotene


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Salivary equivalent<br>Single dose stick without any active substance | Device: Salivary equivalent<br>* 14-day treatment with salivary equivalent sticks<br>|
| Sham Comparator: Aequasyal<br>Multidose moisturizing oral spray without any active substance | Device: Aequasyal<br>* 14-day treatment with Aequasyal oral spray<br>|
| Sham Comparator: Biotene<br>Multidose moisturizing oral spray without any active substance | Device: Biotene<br>* 14-day treatment with Biotene oral spray<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mouth burning sensation | Patient evaluation through the completion of a self rated 100 mm long VAS score. | 14 days | 
| Speech difficulties | Patient evaluation through the completion of a self rated 100 mm long VAS score. | 14 days | 
| Chewing difficulties | Patient evaluation through the completion of a self rated 100 mm long VAS score. | 14 days | 
| Swallowing difficulties | Patient evaluation through the completion of a self rated 100 mm long VAS score. | 14 days | 
| Taste perversion | Patient evaluation through the completion of a self rated 100 mm long VAS score. | 14 days | 
| Medical device acceptability | Patient evaluation through the completion of a self rated 100 mm long VAS score. | 14 days | 
| Medical device safety assessment | Patient evaluation through the completion of a self rated 100 mm long VAS score. | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cross-over, Salivary equivalent, Dry mouth, Medical device