At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 76 enrolled
Drug / intervention
Artificial Saliva +1 moredrug
Likely dose
Artificial Saliva 5mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Xerostomy Treatment in Patients With Sjogren's Syndrome in Chile :A Double Blind Control Trial Comparing Orally Pilocarpine Drops and Artificial Saliva
In Brief
A Phase 4 clinical trial evaluating pilocarpine and Artificial Saliva for Primary Sjogren and 2 related conditions. Completed, enrolled 76 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Sjogren, Secondary Sjogren, Xerostomia
CountriesChile
CollaboratorsFormulario MAgistral Farmacias Ahumada
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2006
First PostedFeb 2007
Primary CompletionMay 2008
TodayJul 2026
First PostedFeb 21, 2007
Enrollment StartNov 1, 2006
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 19.4 years ago
Interventions
pilocarpineprocedure
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
Artificial Salivadrug
5ml 3 times daily