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

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ClinicalTrials.gov Identifier: NCT02049112
Recruitment Status : Completed
First Posted : January 29, 2014
Last Update Posted : January 29, 2014
Sponsor:
Information provided by (Responsible Party):
Unither Pharmaceuticals, France

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


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Study Type : Interventional  (Clinical Trial)
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 : January 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02049112


Locations
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France
Leopold Bellan Private Hospital
Magnanville, France, 78200
Sponsors and Collaborators
Unither Pharmaceuticals, France
Investigators
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Principal Investigator: Michel SALOM, Medical Leopold Bellan Fundation

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Responsible Party: Unither Pharmaceuticals, France
ClinicalTrials.gov Identifier: NCT02049112     History of Changes
Other Study ID Numbers: UN/2011/001
First Posted: January 29, 2014    Key Record Dates
Last Update Posted: January 29, 2014
Last Verified: January 2014
Keywords provided by Unither Pharmaceuticals, France:
Cross-over
Salivary equivalent
Dry mouth
Medical device
Additional relevant MeSH terms:
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Sjogren's Syndrome
Xerostomia
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Muramidase
Anti-Infective Agents