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Clinical Trials/NL-OMON48000
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Academisch Centrum Tandheelkunde Amsterdam (ACTA)

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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