Exploratory Study in the Relief of Drug-induced Xerostomia Associated With Hyposialia

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the clinical efficacy, the safety and acceptability of three new oral sprays with a reference oral spray in the relief of drug-induced xerostomia associated with hyposialia, i.e. dryness of the mouth induced by a decrease of salivation (hyposialia) induced by chronic drug intake.

Official Title
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Study of the Effect and Safety of Three New Oral Sprays and a Reference Marketed Oral Spray in the Relief of Drug-induced Xerostomia Associated With Hyposialia.

Conditions
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Drug-induced Xerostomia

Intervention / Treatment
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* Device: Tested product : DC161-DP0291
* Device: Tested product : DC161-DP0292
* Device: Tested product : DC161-DP0293
* Device: Reference product: solution for oromucosal sprays


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects, Adult subjects (≥18 years) taking drug(s) causing salivary hypofunction / xerostomia, for at least 1 week prior to study initiation and expected to continue without change during study Subjects with a complaint of dry mouth as assessed by a response of 40mm or greater on item Rate the dryness of your mouth of the Dry Mouth Visual Analogue Scale (VAS) questions. (The VAS limits will be 0 representing normal [i.e. no dry mouth symptoms] and 100 representing the worst imaginable dry mouth symptoms). This score should also be met before the 1st product application, on P1 D1. Documented hyposalivation with test of resting saliva weight absorbed ≤ 0.5g/5 min at baseline Exclusion Criteria: Presence of disorders (bucco-dental disease, history of major medical/psychiatric illness or surgery, ... ) which, in the judgement of the investigator, may interfere with study implementation and/or study parameter assessment(s). Sjögren syndrome and related autoimmune diseases, Other medical causes of xerostomia (oral candidiasis). History of head and neck irradiation and cancer chemotherapy History of hypersensitivity to any of the components of the investigational products, History or current excessive use of alcohol, History of drug addiction, Presence of treatments for their dry mouth within 7 days prior to inclusion into the study

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: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cross-over<br>Four periods separated by a wash out lasting up to 3 days at maximum. At each period, application of one product (twice). Duration of treatment period: From 4 to 13 days. | Device: Tested product : DC161-DP0291<br>* Application of product in the mouth twice daily<br>Device: Tested product : DC161-DP0292<br>* Application of product in the mouth twice daily<br>Device: Tested product : DC161-DP0293<br>* Application of product in the mouth twice daily<br>Device: Reference product: solution for oromucosal sprays<br>* Application of product in the mouth twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observed area under the curve of dry mouth evaluations | Dry mouth will be self-rated using item Rate the dryness of your mouth of the Dry Mouth Visual Analogue Scale questions. | 11 points : from baseline (before application) and up to 4 hours after the first product application | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xerostomia, hyposialia, hyposalivation, saliva substitute, Salivary Gland, Mouth Diseases, Dry mouth