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. (NIAGARA)

NCT02049112 Phase 4 COMPLETED

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.

Details

Lead sponsor	Unither Pharmaceuticals, France
Phase	Phase 4
Status	COMPLETED
Enrolment	210
Start date	2012-01
Completion	2013-06

Conditions

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

Interventions

• Salivary equivalent
• Aequasyal
• Biotene

Primary outcomes

• Dry mouth discomfort — 14 days
  Patient evaluation through the completion of a self rated 100 mm long VAS score. Anchor points of the VAS score will be 0 representing the absence of any dry mouth symptoms and 100 representing the worst imaginable picture of dry mouth discomfort

Countries

France