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

Head and Neck Cancer Clinical Trial

— NIAGARA  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02049112
• Other study ID #: UN/2011/001
• Status: Completed
• Phase: Phase 4
• First received: January 27, 2014
• Last updated: January 27, 2014
• Start date: January 2012
• Est. completion date: June 2013

Study information

• Verified date: January 2014
• Source: Unither Pharmaceuticals, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

200 evaluable patients have been recruited

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: June 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Hyposalivation
• Sjögren Syndrome
• Sjogren's Syndrome
• Xerostomia

Intervention

Device:
• Salivary equivalent
14-day treatment with salivary equivalent sticks
• Aequasyal
14-day treatment with Aequasyal oral spray
• Biotene
14-day treatment with Biotene oral spray

Locations

Country	Name	City	State
France	Leopold Bellan Private Hospital	Magnanville

Sponsors (1)

Lead Sponsor	Collaborator
Unither Pharmaceuticals, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dry mouth discomfort	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	14 days
Secondary	Mouth burning sensation	Patient evaluation through the completion of a self rated 100 mm long VAS score.	14 days
Secondary	Speech difficulties	Patient evaluation through the completion of a self rated 100 mm long VAS score.	14 days
Secondary	Chewing difficulties	Patient evaluation through the completion of a self rated 100 mm long VAS score.	14 days
Secondary	Swallowing difficulties	Patient evaluation through the completion of a self rated 100 mm long VAS score.	14 days
Secondary	Taste perversion	Patient evaluation through the completion of a self rated 100 mm long VAS score.	14 days
Secondary	Medical device acceptability	Patient evaluation through the completion of a self rated 100 mm long VAS score.	14 days
Secondary	Medical device safety assessment	Patient evaluation through the completion of a self rated 100 mm long VAS score.	14 days