XerostomiaPhase 4GenNarinoNCT00509808
Evaluation of an Electro-stimulator for the Treatment of Xerostomia
A Phase 4 study testing Electrostimulation in people with Xerostomia, run by Saliwell Ltd. at 1 site in Finland.
Trial summary
This is a multinational trial, aimed at testing the safety and performance of a electrostimulating device ("GenNarino") to treat dry mouth, over one year. The design is as follows: Multi-center, double blind, sham (placebo) controlled, about 10 xerostomia patients per center Patients receive a GenNarino (and its… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Xerostomia
- What is being tested?
- Electrostimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2007to Apr 2010
- 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
- The patient must be at least 18 years of age.
- The patient must have clinical symptoms of xerostomia (dry mouth) due to
- Primary or secondary Sjögren's syndrome
- Medication intake
- Head and neck radiation with survival expectancy of more than one year
- Chronic graft vs. host disease with survival expectancy of more than one year
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- Patients are requested not to take systemic sialogogues during the first 2 months of the study (when active is tested vs. sham)
- Female patients of child bearing potential must have a negative pregnancy test within twenty-four hours of enrollment.
- The patient must understand and consent in writing to the procedure.
- The patient agrees to undergo all examinations and clinical evaluations planned for the study.
Who cannot join
- Active HIV or HCV infection
- Severe systemic disease
- Known allergy to materials similar to be used in the investigational product
- Known mental disease
- Presence of depression, by positive answers to both the following questions:
- "During the past month have you often been bothered by feeling down, depressed or hopeless?"
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- "During the past month have you often been bothered by little interest or pleasure in doing things?"
- Patients wearing other active implants like pacemaker or defibrillator
- Patients with poor oral hygiene
- Patients whose oral anatomical characteristics precludes the insertion of the device
- Patients who are unable or unwilling to cooperate with study procedures.
- Pregnancy
- Presence of erosive or ulcerative oral lesions, which are chronic or recurrent, such as erosive lichen planus, RAS, eryth. Candidosis, and of suspected pre-malignant or malignant lesions
Trial locations and contacts
1 site in 1 country.
Finland1 site
Helsinki University Central Hospital and University of Helsinki
Helsinki, 00014
About this study
Official title: Safety and Performance Evaluation of an Electro-stimulator Mounted on an Intra-oral Removable Appliance (Saliwell GenNarino) for the Treatment of Xerostomia
This is a multinational trial, aimed at testing the safety and performance of a electrostimulating device ("GenNarino") to treat dry mouth, over one year. The design is as follows:
- Multi-center, double blind, sham (placebo) controlled, about 10 xerostomia patients per center
- Patients receive a GenNarino (and its remote control) that is programmed for one month sham and one month active mode (the order of which is randomly assigned), and thereafter 9 months at the active mode (divided in period of 3 months, the order of each is randomly assigned at wearing GenNarino for 1, 5 or 10 minutes at a time).
Read more
Study hypothesis: Gennarino will lead to significant symptomatic improvement
- At the clinic: monthly examinations at the first 2 months, and then every 3 months, including whole saliva collection and questionnaire; at the first visit impression taking for GenNarino preparation
Read the detailed description
The clinical trial, titled "Safety and performance evaluation of an electro-stimulator mounted on an intra-oral removable appliance (GenNarino) for the treatment of xerostomia" is a prospective, randomized, double-blind, sham-controlled multi-center trial, followed by an open-label study. Study subjects are patients with xerostomia. The purpose of the trial is to test the safety and efficacy of electrostimulation using the GenNarino device.
The primary endpoint is significant symptomatic improvement, and the secondary ones, increased salivary output and event free use (no adverse side-effects). The clinical follow-up consists of periodic clinical examinations.
In this clinical trial the use of the device is compared between active vs. sham mode for one month each in a double-blind design (Stage I). Thereafter, at Stage II the xerostomia relieving effect of the active device is assessed in an open label design for additional 6 months. Clinic- and home-based questionnaires and whole saliva collections are performed.
- Conditions
- Xerostomia
- Being tested
- Electrostimulation
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrostimulationDevice
Also called GenNarino
- 1st month GN wearing (activated or sham mode)
- 2nd month wearing (opposite mode)
- 3rd - 5th month: activated GN wearing for 1, 5 or 10 minutes
- 6th - 8th month: activated GN wearing for 1, 5 or 10 minutes
- 9th - 11th month: activated GN wearing for 1, 5 or 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| electrostimulation | Sham comparator | Use of device for predetermined length Receives: Device: Electrostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant symptomatic improvement
Measured: 1 year
Secondary outcomes (1)
1- Increased salivary output 2- Event free use (no adverse side-effects)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2007 (estimated)
- Study startJan 2007
- Primary completionApr 2008
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saliwell Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universidad El Bosque, Bogotá, Charite University, Berlin, Germany, University of Zagreb, McGill University, Istanbul University, Hebrew University of Jerusalem, Universita degli Studi di Palermo, Universidad Nacional Autonoma de Mexico, Skane University Hospital, University of Brasilia, Hospital San Carlos, Madrid, University of Kentucky, University of Helsinki, Indiana University
- Investigators
- Andy Wolff, DMD, Study director, Saliwell Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00509808
- Sponsor's protocol ID
- 1-Wolff
- Acronym
- GenNarino
- Status last verified
- Apr 2010
- First submitted
- 31 Jul 2007
- Last updated
- 6 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Strietzel FP, Lafaurie GI, Mendoza GR, Alajbeg I, Pejda S, Vuletic L, Mantilla R, Falcao DP, Leal SC, Bezerra AC, Tran SD, Menard HA, Kimoto S, Pan S, Martin-Granizo RA, Lozano ML, Zunt SL, Krushinski CA, Melilli D, Campisi G, Paderni C, Dolce S, Yepes JF, Lindh L, Koray M, Mumcu G, Elad S, Zeevi I, Barrios BC, Lopez Sanchez RM, Beiski BZ, Wolff A, Konttinen YT. Efficacy and safety of an intraoral electrostimulation device for xerostomia relief: a multicenter, randomized trial. Arthritis Rheum. 2011 Jan;63(1):180-90. doi: 10.1002/art.27766.
PubMed 20882668
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance Evaluation of an Electro-stimulator Mounted on an Intra-oral Removable Appliance (Saliwell GenNarino) for the Treatment of Xerostomia
- ClinicalTrials.gov ID
- NCT00509808
- Acronym / sponsor ID
- GenNarino / 1-Wolff
- Conditions
- Xerostomia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Saliwell Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Universidad El Bosque, Bogotá, Charite University, Berlin, Germany, University of Zagreb, McGill University, Istanbul University, Hebrew University of Jerusalem, Universita degli Studi di Palermo, Universidad Nacional Autonoma de Mexico, Skane University Hospital, University of Brasilia, Hospital San Carlos, Madrid, University of Kentucky, University of Helsinki, Indiana University
- Study start
- Jan 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 1 Aug 2007 (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.
This is a multinational trial, aimed at testing the safety and performance of a electrostimulating device ("GenNarino") to treat dry mouth, over one year. The design is as follows:
- Multi-center, double blind, sham (placebo) controlled, about 10 xerostomia patients per center
- Patients receive a GenNarino (and its remote control) that is programmed for one month sham and one month active mode (the order of which is randomly assigned), and thereafter 9 months at the active mode (divided in period of 3 months, the order of each is randomly assigned at wearing GenNarino for 1, 5 or 10 minutes at a time).
Study hypothesis: Gennarino will lead to significant symptomatic improvement
- At the clinic: monthly examinations at the first 2 months, and then every 3 months, including whole saliva collection and questionnaire; at the first visit impression taking for GenNarino preparation
Detailed description
The clinical trial, titled "Safety and performance evaluation of an electro-stimulator mounted on an intra-oral removable appliance (GenNarino) for the treatment of xerostomia" is a prospective, randomized, double-blind, sham-controlled multi-center trial, followed by an open-label study. Study subjects are patients with xerostomia. The purpose of the trial is to test the safety and efficacy of electrostimulation using the GenNarino device.
The primary endpoint is significant symptomatic improvement, and the secondary ones, increased salivary output and event free use (no adverse side-effects). The clinical follow-up consists of periodic clinical examinations.
In this clinical trial the use of the device is compared between active vs. sham mode for one month each in a double-blind design (Stage I). Thereafter, at Stage II the xerostomia relieving effect of the active device is assessed in an open label design for additional 6 months. Clinic- and home-based questionnaires and whole saliva collections are performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| electrostimulation | Sham comparator | Device: ElectrostimulationUse of device for predetermined length |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The patient must be at least 18 years of age.
- The patient must have clinical symptoms of xerostomia (dry mouth) due to
- Patients are requested not to take systemic sialogogues during the first 2 months of the study (when active is tested vs. sham)
- Female patients of child bearing potential must have a negative pregnancy test within twenty-four hours of enrollment.
- The patient must understand and consent in writing to the procedure.
Key exclusion criteria (13 listed)
- Active HIV or HCV infection
- Severe systemic disease
- Known allergy to materials similar to be used in the investigational product
- Known mental disease
- Presence of depression, by positive answers to both the following questions:
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 |
|---|---|---|
| ElectrostimulationAlso: GenNarino1. 1st month GN wearing (activated or sham mode) 2. 2nd month wearing (opposite mode) 3. 3rd - 5th month: activated GN wearing for 1, 5 or 10 minutes 4. 6th - 8th month: activated GN wearing for 1, 5 or 10 minutes 5. 9th - 11th month: activated GN wearing for 1, 5 or 10 minutes | Device | electrostimulation |
Primary outcome
Significant symptomatic improvement
Time frame: 1 year
1 secondary outcome
1- Increased salivary output 2- Event free use (no adverse side-effects)
Time frame: 1 year
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 6 Apr 2010.
- Derived from this study: PubMed 20882668Strietzel FP, Lafaurie GI, Mendoza GR, Alajbeg I, Pejda S, Vuletic L, Mantilla R, Falcao DP, Leal SC, Bezerra AC, Tran SD, Menard HA, Kimoto S, Pan S, Martin-Granizo RA, Lozano ML, Zunt SL, Krushinski CA, Melilli D, Campisi G, Paderni C, Dolce S, Yepes JF, Lindh L, Koray M, Mumcu G, Elad S, Zeevi I, Barrios BC, Lopez Sanchez RM, Beiski BZ, Wolff A, Konttinen YT. Efficacy and safety of an intraoral electrostimulation device for xerostomia relief: a multicenter, randomized trial. Arthritis Rheum. 2011 Jan;63(1):180-90. doi: 10.1002/art.27766.
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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.
Andy Wolff, DMD study director
Saliwell Ltd.
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 Electrostimulation in people with Xerostomia, run by Saliwell Ltd. at 1 site in Finland.
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 10 inclusion and 13 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 6 Apr 2010. 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 Finland. 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?
Significant symptomatic improvement (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00509808, which also lists 1 linked publication.
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 6 Apr 2010.