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

Unither Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Xerostomia; Sjögren Syndrome; Hyposalivation; Head and Neck Cancer

Treatments: Device: Aequasyal; Device: Salivary equivalent; Device: Biotene

Study type: Interventional

Funder types: Industry

Identifiers

NCT02049112

UN/2011/001

Details and patient eligibility

About

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.

Full description

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

200 evaluable patients have been recruited

Enrollment: 210 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

210 participants in 3 patient groups

Salivary equivalent

Experimental group

Description:

Single dose stick without any active substance

Treatment:

Device: Salivary equivalent

Aequasyal

Sham Comparator group

Description:

Multidose moisturizing oral spray without any active substance

Treatment:

Device: Aequasyal

Biotene

Sham Comparator group

Description:

Multidose moisturizing oral spray without any active substance

Treatment:

Device: Biotene