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

Head and Neck Cancer Clinical Trial

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.

Clinical Trial 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.

Clinical Trial Description

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

200 evaluable patients have been recruited ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02049112
Study type Interventional
Source Unither Pharmaceuticals, France
Contact
Status Completed
Phase Phase 4
Start date January 2012
Completion date June 2013
View Details
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