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Brief Title: A New Oral salIvary equivAlent Compared to Two moisturizinG Mouth sprAys in Patients With xeRostomiA: NIAGARA Study
Official Title: 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.
Study ID: 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.
Detailed Description: National, multicentre, randomised, active controlled, crossover, open-label study using a 3-latin-square design. 200 evaluable patients have been recruited
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Leopold Bellan Private Hospital, Magnanville, , France
Name: Michel SALOM, Medical
Affiliation: Leopold Bellan Fundation
Role: PRINCIPAL_INVESTIGATOR