Drug-induced Xerostomia
Conditions
Keywords
Xerostomia, hyposialia, hyposalivation, saliva substitute, Salivary Gland, Mouth Diseases, Dry mouth
Brief summary
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.
Interventions
DEVICETested product : DC161-DP0291
Application of product in the mouth twice daily
DEVICETested product : DC161-DP0292
Application of product in the mouth twice daily
DEVICETested product : DC161-DP0293
Application of product in the mouth twice daily
DEVICEReference product: solution for oromucosal sprays
Application of product in the mouth twice daily
Sponsors
Pierre Fabre Medicament
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observed area under the curve of dry mouth evaluations | 11 points : from baseline (before application) and up to 4 hours after the first product application | Dry mouth will be self-rated using item Rate the dryness of your mouth of the Dry Mouth Visual Analogue Scale questions. |
Countries
Germany
Outcome results
None listed