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Evaluation of an Electro-stimulator for the Treatment of Xerostomia (GenNarino)

Primary Purpose

Xerostomia

Status

Completed

Phase

Phase 4

Locations

Finland

Study Type

Interventional

Intervention

Electrostimulation

About this trial

This is an interventional treatment trial for Xerostomia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
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.

Exclusion Criteria:

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?"
- "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

Sites / Locations

Helsinki University Central Hospital and University of Helsinki

Arms of the Study

Arm 1

Arm Type

Sham Comparator

Arm Label

electrostimulation

Arm Description

Use of device for predetermined length

Outcomes

Primary Outcome Measures

Significant symptomatic improvement

Secondary Outcome Measures

1- Increased salivary output 2- Event free use (no adverse side-effects)

Full Information

NCT ID

NCT00509808

First Posted

July 31, 2007

Last Updated

April 5, 2010

Sponsor

Saliwell Ltd.

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

1. Study Identification

Unique Protocol Identification Number

NCT00509808

Brief Title

Evaluation of an Electro-stimulator for the Treatment of Xerostomia

Acronym

GenNarino

Official Title

Safety and Performance Evaluation of an Electro-stimulator Mounted on an Intra-oral Removable Appliance (Saliwell GenNarino) for the Treatment of Xerostomia

Study Type

Interventional

2. Study Status

Record Verification Date

April 2010

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

April 2008 (Actual)

Study Completion Date

April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Saliwell Ltd.

Collaborators

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Xerostomia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

electrostimulation

Arm Type

Sham Comparator

Arm Description

Use of device for predetermined length

Intervention Type

Device

Intervention Name(s)

Electrostimulation

Other Intervention Name(s)

GenNarino

Intervention Description

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

Primary Outcome Measure Information:

Title

Significant symptomatic improvement

Time Frame

1 year

Secondary Outcome Measure Information:

Title

1- Increased salivary output 2- Event free use (no adverse side-effects)

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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. Exclusion Criteria: 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?" "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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andy Wolff, DMD

Organizational Affiliation

Saliwell Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

Helsinki University Central Hospital and University of Helsinki

City

Helsinki

ZIP/Postal Code

00014

Country

Finland

12. IPD Sharing Statement

Citations:

PubMed Identifier

20882668

Citation

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.

Results Reference

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Evaluation of an Electro-stimulator for the Treatment of Xerostomia

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