Clinical trial NCT02049112: A New Oral salIvary equivAlent Compared to Two moisturizinG Mouth sprAys in Patients With xeRostomiA: NIAGARA Study
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Xerostomia
Hyposalivation
Head and Neck Cancer
Sjögren Syndrome
Keywords: Cross-over
Salivary equivalent
Dry mouth
Medical device
Lead sponsor: Unither Pharmaceuticals, France
Sponsor class: INDUSTRY
First posted: 2014-01-29
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Dry mouth discomfort
timeFrame: 14 days
Secondary outcomes:
measure: Mouth burning sensation
timeFrame: 14 days
measure: Speech difficulties
timeFrame: 14 days
measure: Chewing difficulties
timeFrame: 14 days
measure: Swallowing difficulties
timeFrame: 14 days
measure: Taste perversion
timeFrame: 14 days
measure: Medical device acceptability
timeFrame: 14 days
measure: Medical device safety assessment
timeFrame: 14 days
Other outcomes:
Locations:
city: Magnanville
country: France
facility: Leopold Bellan Private Hospital
Study officials:
affiliation: Leopold Bellan Fundation
name: Michel SALOM, Medical
role: PRINCIPAL_INVESTIGATOR
References: