A New Oral salIvary equivAlent Compared to Two moisturizinG Mouth sprAys in Patients With xeRosto… (NCT02049112) | Clinical Trial Compass
CompletedPhase 4
A New Oral salIvary equivAlent Compared to Two moisturizinG Mouth sprAys in Patients With xeRostomiA: NIAGARA Study
France210 participantsStarted 2012-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 th…