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Completed

NCT Number: NCT02049112

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

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.

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Key information

Conditions

Xerostomia Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Head and Neck Cancer Head and Neck Neoplasms Hyposalivation Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Mouth Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Site Rheumatic Diseases Salivary Gland Diseases Sjogren's Syndrome Sjögren Syndrome Skin and Connective Tissue Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Leopold Bellan Private Hospital

Magnanville, 78200, France

About this study

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

200 evaluable patients have been recruited

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Salivary equivalent

Device

14-day treatment with salivary equivalent sticks

Aequasyal

Device

14-day treatment with Aequasyal oral spray

Biotene

Device

14-day treatment with Biotene oral spray

Primary outcomes

  1. 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

Secondary outcomes

  1. Mouth burning sensation

    Time frame: 14 days

    Patient evaluation through the completion of a self rated 100 mm long VAS score.

  2. Speech difficulties

    Time frame: 14 days

    Patient evaluation through the completion of a self rated 100 mm long VAS score.

  3. Chewing difficulties

    Time frame: 14 days

    Patient evaluation through the completion of a self rated 100 mm long VAS score.

  4. Swallowing difficulties

    Time frame: 14 days

    Patient evaluation through the completion of a self rated 100 mm long VAS score.

  5. Taste perversion

    Time frame: 14 days

    Patient evaluation through the completion of a self rated 100 mm long VAS score.

  6. Medical device acceptability

    Time frame: 14 days

    Patient evaluation through the completion of a self rated 100 mm long VAS score.

  7. Medical device safety assessment

    Time frame: 14 days

    Patient evaluation through the completion of a self rated 100 mm long VAS score.

Sponsors and collaborators

Lead sponsor

Unither Pharmaceuticals, France

Industry

Registry information

Official study 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.

Acronym: NIAGARA

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 29, 2014
Registry last updated
Jan 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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