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

Phase 4

Completed

• Conditions: Hyposalivation; Xerostomia; Head and Neck Cancer; Sjögren Syndrome
• Interventions: Device: Biotene; Device: Aequasyal; Device: Salivary equivalent

• Registration Number: NCT02049112
• Lead Sponsor: Unither Pharmaceuticals, France

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

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2013-04
• Study Completion: 2013-06
• Status Verified: 2014-01
• Study First Submitted: 2014-01-27
• Study First Submitted QC: 2014-01-27
• Last Update Submitted: 2014-01-27
• Study First Posted: 2014-01-29
• Last Update Posted: 2014-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Patients:

• Aged 18 years or more,
• Clinical diagnosis of xerostomia by a severe reduction of salivation, as detected by patient's answers to few specific questions and measured by saliva volume at screening visit (test of saliva weight absorbed ≤ 0.1g/min)
• Any medical condition or treatment leading to a severe reduction of salivation related to either:
• Head and neck radiation therapy for cancer,
• Gougerot-Sjögren syndrome
• Medications known to induce xerostomia (psychotropic drugs, antihypertensive drugs)
• Dehydration, hypothyroidism, Parkinson's disease and/or diabetes mellitus
• Female patients must be post-menopausal or using a highly effective method for avoidance of pregnancy throughout the whole study duration, if childbearing potential.
• Able to understand and comply with the protocol procedures
• Willing and able to give their written informed consent
• Affiliated to the French National Health Insurance Program

Exclusion Criteria

• Known hypersensitivity to one of the study products or to one of their components
• Any planned change in dosing of all known medications inducing mouth dryness
• Concomitant treatment for xerostomia symptoms without a scheduled 3 to 7-day withdrawal window
• Oral candidiasis as diagnosed by a microbiological test obtained from an unstimulated whole saliva sample until 3-week period from disease release
• Oral ulceration
• Alcohol (>2 glasses of wine/day), smoking (>10 cigarettes/day), caffeine and/or theine intake (>4 cups/day)
• Patients unable to fill out the questionnaires or to comply with the study protocol
• Dental infection
• Patients participating to another clinical trial at the time of the study entry or within 30 days prior to study enrolment
• Life-threatening condition at the time of the study
• Pregnant or lactating women and women of childbearing potential refusing to use adequate contraception.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Biotene	Biotene	Multidose moisturizing oral spray without any active substance
Aequasyal	Aequasyal	Multidose moisturizing oral spray without any active substance
Salivary equivalent	Salivary equivalent	Single dose stick without any active substance

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Taste perversion	14 days	Patient evaluation through the completion of a self rated 100 mm long VAS score.
Medical device acceptability	14 days	Patient evaluation through the completion of a self rated 100 mm long VAS score.
Medical device safety assessment	14 days	Patient evaluation through the completion of a self rated 100 mm long VAS score.
Mouth burning sensation	14 days	Patient evaluation through the completion of a self rated 100 mm long VAS score.
Speech difficulties	14 days	Patient evaluation through the completion of a self rated 100 mm long VAS score.
Chewing difficulties	14 days	Patient evaluation through the completion of a self rated 100 mm long VAS score.
Swallowing difficulties	14 days	Patient evaluation through the completion of a self rated 100 mm long VAS score.

Trial Locations

Locations (1)

Leopold Bellan Private Hospital; 🇫🇷 Magnanville, France