A Comparison of Orally Pilocarpine and Artificial Saliva in Xerostomy Treatment
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.
Drug: Artificial Saliva
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Xerostomy Treatment in Patients With Sjogren's Syndrome in Chile :A Double Blind Control Trial Comparing Orally Pilocarpine Drops and Artificial Saliva|
- 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. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Determine on a subjetive manner wich treatment is better fot patients. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2006|
|Study Completion Date:||May 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
Active Comparator: a,b
Compare Pilocarpine and Artificial saliva
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
Other Names:Drug: Artificial Saliva
5ml 3 times daily
Xerostomy treatment in patients with Sjogren's syndrome in Chile :A double blind control trial comparing orally Pilocarpine drops and Artificial Saliva
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00438048
|Unidad Docente Asociada Dermatologia. Escuela de MEdicina Pontificia Universidad Catolica de Chile|
|Santiago, Region Metropolitana, Chile|
|Principal Investigator:||Cristian Vera-Kellet, MD||UDA Dermatologia, Escuela de Medicina, Pontificia Universidad Catolica de Chile|