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

Primary Purpose

Xerostomia, Hyposalivation, Head and Neck Cancer

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Salivary equivalent
Aequasyal
Biotene
Sponsored by
Unither Pharmaceuticals, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Xerostomia focused on measuring Cross-over, Salivary equivalent, Dry mouth, Medical device

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Leopold Bellan Private Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Sham Comparator

Arm Label

Salivary equivalent

Aequasyal

Biotene

Arm Description

Single dose stick without any active substance

Multidose moisturizing oral spray without any active substance

Multidose moisturizing oral spray without any active substance

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mouth burning sensation
Patient evaluation through the completion of a self rated 100 mm long VAS score.
Speech difficulties
Patient evaluation through the completion of a self rated 100 mm long VAS score.
Chewing difficulties
Patient evaluation through the completion of a self rated 100 mm long VAS score.
Swallowing difficulties
Patient evaluation through the completion of a self rated 100 mm long VAS score.
Taste perversion
Patient evaluation through the completion of a self rated 100 mm long VAS score.
Medical device acceptability
Patient evaluation through the completion of a self rated 100 mm long VAS score.
Medical device safety assessment
Patient evaluation through the completion of a self rated 100 mm long VAS score.

Full Information

First Posted
January 27, 2014
Last Updated
January 27, 2014
Sponsor
Unither Pharmaceuticals, France
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1. Study Identification

Unique Protocol Identification Number
NCT02049112
Brief Title
A New Oral salIvary equivAlent Compared to Two moisturizinG Mouth sprAys in Patients With xeRostomiA: NIAGARA Study
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unither Pharmaceuticals, France

4. Oversight

Data Monitoring Committee
No

5. 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.
Detailed Description
National, multicentre, randomised, active controlled, crossover, open-label study using a 3-latin-square design. 200 evaluable patients have been recruited

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia, Hyposalivation, Head and Neck Cancer, Sjögren Syndrome
Keywords
Cross-over, Salivary equivalent, Dry mouth, Medical device

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Salivary equivalent
Arm Type
Experimental
Arm Description
Single dose stick without any active substance
Arm Title
Aequasyal
Arm Type
Sham Comparator
Arm Description
Multidose moisturizing oral spray without any active substance
Arm Title
Biotene
Arm Type
Sham Comparator
Arm Description
Multidose moisturizing oral spray without any active substance
Intervention Type
Device
Intervention Name(s)
Salivary equivalent
Intervention Description
14-day treatment with salivary equivalent sticks
Intervention Type
Device
Intervention Name(s)
Aequasyal
Intervention Description
14-day treatment with Aequasyal oral spray
Intervention Type
Device
Intervention Name(s)
Biotene
Intervention Description
14-day treatment with Biotene oral spray
Primary Outcome Measure Information:
Title
Dry mouth discomfort
Description
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
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Mouth burning sensation
Description
Patient evaluation through the completion of a self rated 100 mm long VAS score.
Time Frame
14 days
Title
Speech difficulties
Description
Patient evaluation through the completion of a self rated 100 mm long VAS score.
Time Frame
14 days
Title
Chewing difficulties
Description
Patient evaluation through the completion of a self rated 100 mm long VAS score.
Time Frame
14 days
Title
Swallowing difficulties
Description
Patient evaluation through the completion of a self rated 100 mm long VAS score.
Time Frame
14 days
Title
Taste perversion
Description
Patient evaluation through the completion of a self rated 100 mm long VAS score.
Time Frame
14 days
Title
Medical device acceptability
Description
Patient evaluation through the completion of a self rated 100 mm long VAS score.
Time Frame
14 days
Title
Medical device safety assessment
Description
Patient evaluation through the completion of a self rated 100 mm long VAS score.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel SALOM, Medical
Organizational Affiliation
Leopold Bellan Fundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leopold Bellan Private Hospital
City
Magnanville
ZIP/Postal Code
78200
Country
France

12. IPD Sharing Statement

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

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