Xerostomia Clinical Trial
Official title:
Xerostomy Treatment in Patients With Sjogren's Syndrome in Chile :A Double Blind Control Trial Comparing Orally Pilocarpine Drops and Artificial Saliva
The purpose of this study is to assess and compare the safetyness and efficacy of pilocarpine drops versus artificial saliva as symptomatic treatment for dry mouth and dry eyes caused by SS in a multicenter, doubleblind, controlled trial.
Title:
Xerostomy treatment in patients with Sjogren's syndrome in Chile :A double blind control
trial comparing orally Pilocarpine drops and Artificial Saliva
Authors:
Cristian Vera Kellet, Mirtha Cifuentes Mutinelli. Affiliations: Pontificia Universidad
Catolica de Chile
BACKGROUND Sjogren's syndrome (SS) is characterized by diminished exocrine secretions with
the resultant xerostomia and xerophthalmia due to slowly progressive infiltration of
lacrimal and salivary glands by inflamatory cells.
OBJECTIVE: To assess and compare the safetyness and efficacy of pilocarpine drops versus
artificial saliva as symptomatic treatment for dry mouth and dry eyes caused by SS in a
multicenter, doubleblind, controlled trial.
SUBJECTS AND METHODS After providing written informed consent, 72 patients with primary or
secondary SS and clinically significant dry mouth and dry eyes will be randomized to receive
either 5-mg pilocarpine drops, or artificial saliva 3 times daily for 12 weeks. Global
evaluation and subjective responses of patients will be assessed by questionnaires with
visual analog scales or categorical checkboxes. All patients will be submited to anxiety and
psicological test before and after 12 weeks. Whole-mouth salivary flow and lacrimal flow
will be measured using Schirmer test.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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