A Comparison of Orally Pilocarpine and Artificial Saliva in Xerostomy Treatment

Phase 4

Completed

• Conditions: Primary Sjogren; Secondary Sjogren; Xerostomia
• Interventions: Procedure: pilocarpine; Drug: Artificial Saliva

• Registration Number: NCT00438048
• Lead Sponsor: Pontificia Universidad Catolica de Chile

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2007-02-20
• Study First Submitted QC: 2007-02-20
• Study First Posted: 2007-02-21
• Status Verified: 2008-05
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Last Update Submitted: 2008-05-21
• Last Update Posted: 2008-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
a,b	pilocarpine	Compare Pilocarpine and Artificial saliva
a,b	Artificial Saliva	Compare Pilocarpine and Artificial saliva

Primary Outcome Measures

Name	Time	Method
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.	12 weeks

Secondary Outcome Measures

Name	Time	Method
Determine on a subjetive manner wich treatment is better fot patients.	12 weeks

Trial Locations

Locations (1)

Unidad Docente Asociada Dermatologia. Escuela de MEdicina Pontificia Universidad Catolica de Chile; 🇨🇱 Santiago, Region Metropolitana, Chile