INTERVENTION STUDY FOR THE RELIEF OF ORAL DRYNESS * NOVOSPRAY

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 35

Inclusion Criteria

* Male or female, over 18 years of age, and capable of providing their written
informed consent.
* An unstimulated whole mouth salivary flow < 0.20 ml/min [8].
* Demonstrated moderate to severe level of dry mouth at screening, as indicated
by an XI-score of 25 or higher
* Diagnosis of Sjögren's syndrome.
* Access to internet.

Exclusion Criteria

* Patients currently using a potassium-sparing diuretic antihypertensive drug
that contains amiloride; spironolactone (e.g.,Aldactone, Novo-Spiroton,
Spiractin, Spirtone, Verospiron or Berlactone); triamterene (e.g., Dyrenium);
or plerenone (e.g., Inspra). Chronic use of antihistamines will be permitted if
started at least 30 days before the start of the trial, and a stable dose is
maintained throughout the trial.
* Patients who started using systemic cholinergic secretagogues or tricyclic
antidepressant drugs within 12 weeks before screening, patients who are not on
a stable dosing regimen for at least 14 days prior to the screening visit, or
patients who are unable to maintain stable dosing throughout the study.
* Females who are pregnant or trying to become pregnant, or are nursing.
* Patients showing evidence of a significant active or ongoing oral infection
or other oral conditions (eg, lichen planus) that, in the opinion of the
Investigator, might affect the safety of the subject or be exacerbated during
study participation.
* Patients suffering from acute infections of the salivary glands.
* Patients with a present history of any clinically significant and
uncontrolled neurologic, gastrointestinal, renal, hepatic, cardiovascular,
psychological, pulmonary, metabolic, endocrine, or hematological disorder or
disease, or any other major disorder or disease, in the opinion of the
Investigator.
* Patients consuming more than 2 alcoholic drinks per day or with a significant
history of alcoholism or drug/chemical abuse within the past 12 months.
* Patients who have received an investigational drug within the past 30 days.
* Patients with a history of allergy to chicken egg proteins or food
preservatives
* Patients having an unstimulated whole mouth salivary flow > 0.20 ml/min.
* Patients who are incapable of filling out questionnaires because of cognitive
or physical inability

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameter measured is the evaluation of the alleviation of<br /><br>dryness of the mouth after use of the product, compared to the placebo. This<br /><br>will be measured using questionnaires</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are:<br /><br><br /><br>The appreciation of the product by the volunteers, using a questionnaire<br /><br>The unstimulated salivary flow rate before and after the use of both products.</p><br>