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

January 27, 2014 updated by: Unither Pharmaceuticals, France

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

200 evaluable patients have been recruited

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Magnanville, France, 78200
        • Leopold Bellan Private Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dry mouth discomfort
Time Frame: 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
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mouth burning sensation
Time Frame: 14 days
Patient evaluation through the completion of a self rated 100 mm long VAS score.
14 days
Speech difficulties
Time Frame: 14 days
Patient evaluation through the completion of a self rated 100 mm long VAS score.
14 days
Chewing difficulties
Time Frame: 14 days
Patient evaluation through the completion of a self rated 100 mm long VAS score.
14 days
Swallowing difficulties
Time Frame: 14 days
Patient evaluation through the completion of a self rated 100 mm long VAS score.
14 days
Taste perversion
Time Frame: 14 days
Patient evaluation through the completion of a self rated 100 mm long VAS score.
14 days
Medical device acceptability
Time Frame: 14 days
Patient evaluation through the completion of a self rated 100 mm long VAS score.
14 days
Medical device safety assessment
Time Frame: 14 days
Patient evaluation through the completion of a self rated 100 mm long VAS score.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unither Pharmaceuticals, France

Investigators

  • Principal Investigator: Michel SALOM, Medical, Leopold Bellan Fundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

January 27, 2014

First Submitted That Met QC Criteria

January 27, 2014

First Posted (Estimate)

January 29, 2014

Study Record Updates

Last Update Posted (Estimate)

January 29, 2014

Last Update Submitted That Met QC Criteria

January 27, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UN/2011/001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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