NCT02049112

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

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Unither Pharmaceuticals, France · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Xerostomia
• Hyposalivation
• Head and Neck Cancer
• Sjögren Syndrome

Interventions

Type	Name	Description
DEVICE	Salivary equivalent	14-day treatment with salivary equivalent sticks
DEVICE	Aequasyal	14-day treatment with Aequasyal oral spray
DEVICE	Biotene	14-day treatment with Biotene oral spray

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-04-01
• Completion: 2013-06-01
• First posted: 2014-01-29
• Last updated: 2014-01-29

Locations

1 site across 1 country: France