XerostomiaPhase 4NIAGARANCT02049112
A New Oral salIvary equivAlent Compared to Two moisturizinG Mouth sprAys in Patients With xeRostomiA: NIAGARA Study
A Phase 4 study testing Salivary equivalent, Aequasyal and Biotene in people with Xerostomia and Hyposalivation, run by Unither Pharmaceuticals, France at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Xerostomia, Hyposalivation, Head and Neck Cancer
- What is being tested?
- Salivary equivalent, Aequasyal and Biotene
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Jun 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the detailed description
National, multicentre, randomised, active controlled, crossover, open-label study using a 3-latin-square design.
200 evaluable patients have been recruited
- Conditions
- Xerostomia, Hyposalivation, Head and Neck Cancer, Sjögren Syndrome
- Being tested
- Salivary equivalent, Aequasyal, Biotene
- Keywords
- Cross-over, Salivary equivalent, Dry mouth, Medical device
- Medical subject headings
- Xerostomia, Head and Neck Neoplasms, Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salivary equivalentDevice
14-day treatment with salivary equivalent sticks
AequasyalDevice
14-day treatment with Aequasyal oral spray
BioteneDevice
14-day treatment with Biotene oral spray
| Study group | Role | What they receive |
|---|---|---|
| Salivary equivalent | Experimental | Single dose stick without any active substance Receives: Device: Salivary equivalent |
| Aequasyal | Sham comparator | Multidose moisturizing oral spray without any active substance Receives: Device: Aequasyal |
| Biotene | Sham comparator | Multidose moisturizing oral spray without any active substance Receives: Device: Biotene |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days
Secondary outcomes (7)
Mouth burning sensation
Patient evaluation through the completion of a self rated 100 mm long VAS score.
Measured: 14 days
Speech difficulties
Patient evaluation through the completion of a self rated 100 mm long VAS score.
Measured: 14 days
Chewing difficulties
Patient evaluation through the completion of a self rated 100 mm long VAS score.
Measured: 14 days
Swallowing difficulties
Patient evaluation through the completion of a self rated 100 mm long VAS score.
Measured: 14 days
Taste perversion
Patient evaluation through the completion of a self rated 100 mm long VAS score.
Measured: 14 days
Medical device acceptability
Patient evaluation through the completion of a self rated 100 mm long VAS score.
Measured: 14 days
Medical device safety assessment
Patient evaluation through the completion of a self rated 100 mm long VAS score.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startJan 2012
- Primary completionApr 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for XerostomiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unither Pharmaceuticals, France
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michel SALOM, Medical, Principal investigator, Leopold Bellan Fundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049112
- Sponsor's protocol ID
- UN/2011/001
- Acronym
- NIAGARA
- Status last verified
- Jan 2014
- First submitted
- 27 Jan 2014
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02049112
- Acronym / sponsor ID
- NIAGARA / UN/2011/001
- Conditions
- Xerostomia, Hyposalivation, Head and Neck Cancer, Sjögren Syndrome
- Keywords
- Cross-over, Salivary equivalent, Dry mouth, Medical device
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Unither Pharmaceuticals, FranceIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 29 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Salivary equivalent | Experimental | Device: Salivary equivalentSingle dose stick without any active substance |
| Aequasyal | Sham comparator | Device: AequasyalMultidose moisturizing oral spray without any active substance |
| Biotene | Sham comparator | Device: BioteneMultidose moisturizing oral spray without any active substance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salivary equivalent14-day treatment with salivary equivalent sticks | Device | Salivary equivalent |
| Aequasyal14-day treatment with Aequasyal oral spray | Device | Aequasyal |
| Biotene14-day treatment with Biotene oral spray | Device | Biotene |
Primary outcome
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
7 secondary outcomes
Mouth burning sensation
Time frame: 14 days
Speech difficulties
Time frame: 14 days
Chewing difficulties
Time frame: 14 days
Swallowing difficulties
Time frame: 14 days
Taste perversion
Time frame: 14 days
Medical device acceptability
Time frame: 14 days
Medical device safety assessment
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel SALOM, Medical principal investigator
Leopold Bellan Fundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Salivary equivalent, Aequasyal and Biotene in people with Xerostomia and Hyposalivation, run by Unither Pharmaceuticals, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dry mouth discomfort (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2014.