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

Sponsor

Unither Pharmaceuticals, France (Industry)

Overall Status

Completed

CT.gov ID

NCT02049112

Collaborator

(none)

210

Enrollment

Location

Arms

Duration (Months)

12.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Xerostomia Hyposalivation Head and Neck Cancer Sjögren Syndrome	Device: Salivary equivalent Device: Aequasyal Device: Biotene	Phase 4

Detailed Description

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

200 evaluable patients have been recruited

Study Design

Study Type:

Interventional

Actual Enrollment :

210 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Salivary equivalent Single dose stick without any active substance	Device: Salivary equivalent 14-day treatment with salivary equivalent sticks
Sham Comparator: Aequasyal Multidose moisturizing oral spray without any active substance	Device: Aequasyal 14-day treatment with Aequasyal oral spray
Sham Comparator: Biotene Multidose moisturizing oral spray without any active substance	Device: Biotene 14-day treatment with Biotene oral spray

Arm

Intervention/Treatment

Experimental: Salivary equivalent

Single dose stick without any active substance

Device: Salivary equivalent

14-day treatment with salivary equivalent sticks

Sham Comparator: Aequasyal

Multidose moisturizing oral spray without any active substance

Device: Aequasyal

14-day treatment with Aequasyal oral spray

Sham Comparator: Biotene

Multidose moisturizing oral spray without any active substance

Device: Biotene

14-day treatment with Biotene oral spray

Outcome Measures

Primary Outcome Measures

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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.