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A Comparison of Orally Pilocarpine and Artificial Saliva in Xerostomy Treatment

NCT00438048 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2008-05-22

No results posted yet for this study

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.

Conditions

  • Primary Sjogren
  • Secondary Sjogren
  • Xerostomia

Interventions

PROCEDURE

pilocarpine

or secondary symptomatic SS with clinically significant dry mouth were randomized to receive either 5 mg oral Pilocarpine solution (5ml) or artificial saliva (5 ml) 3 times a day for 12 weeks

DRUG

Artificial Saliva

5ml 3 times daily

Sponsors & Collaborators

  • Formulario MAgistral Farmacias Ahumada

    collaborator UNKNOWN

  • Pontificia Universidad Catolica de Chile

    lead OTHER

Principal Investigators

  • Cristian Vera-Kellet, MD · UDA Dermatologia, Escuela de Medicina, Pontificia Universidad Catolica de Chile

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00438048 on ClinicalTrials.gov