A Comparison of Orally Pilocarpine and Artificial Saliva in Xerostomy Treatment

Pontificia Universidad Catolica de Chile

Status and phase: Completed; Phase 4

Conditions: Xerostomia; Primary Sjogren; Secondary Sjogren

Treatments: Procedure: pilocarpine; Drug: Artificial Saliva

Study type: Interventional

Funder types: Other

Identifiers

NCT00438048

CAVK-130108245-1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patiens over 18 years, with primary or secondary Sjogren's Syndrome and xerostomia.

Exclusion criteria

• Patiens with cardiac, pulmonary, renal, gastric diseases,
• Patients with diabetes, glaucoma, Multipleesclerosis,
• Pregnant women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 1 patient group

a,b

Active Comparator group

Description:

Compare Pilocarpine and Artificial saliva

Treatment:

Drug: Artificial Saliva

Procedure: pilocarpine