NL-OMON48000
Completed
Not Applicable
INTERVENTION STUDY FOR THE RELIEF OF ORAL DRYNESS * NOVOSPRAY - INTERVENTION STUDY FOR THE RELIEF OF ORAL DRYNESS * NOVOSPRAY
Academisch Centrum Tandheelkunde Amsterdam (ACTA)0 sites35 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Academisch Centrum Tandheelkunde Amsterdam (ACTA)
- Enrollment
- 35
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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