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A Comparison of Orally Pilocarpine and Artificial Saliva in Xerostomy Treatment

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ClinicalTrials.gov Identifier: NCT00438048
Recruitment Status : Completed
First Posted : February 21, 2007
Last Update Posted : May 22, 2008
Sponsor:
Collaborator:
Formulario MAgistral Farmacias Ahumada
Information provided by:
Pontificia Universidad Catolica de Chile

February 20, 2007
February 21, 2007
May 22, 2008
November 2006
May 2008   (Final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00438048 on ClinicalTrials.gov Archive Site
Determine on a subjetive manner wich treatment is better fot patients. [ Time Frame: 12 weeks ]
Determine on a subjetive manner wich treatment is better fot patients.
Not Provided
Not Provided
 
A Comparison of Orally Pilocarpine and Artificial Saliva in Xerostomy Treatment
Xerostomy Treatment in Patients With Sjogren's Syndrome in Chile :A Double Blind Control Trial Comparing Orally Pilocarpine Drops and Artificial Saliva
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Primary Sjogren
  • Secondary Sjogren
  • Xerostomia
  • 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
    Other Name: Artificial saliva
  • Drug: Artificial Saliva
    5ml 3 times daily
    Other Name: pilocarpine
Active Comparator: a,b
Compare Pilocarpine and Artificial saliva
Interventions:
  • Procedure: pilocarpine
  • Drug: Artificial Saliva

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
50
May 2008
May 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Chile
 
 
NCT00438048
CAVK-130108245-1
Yes
Not Provided
Not Provided
Cristian Vera Kellet, Pontificia Universidad Católica de Chile
Pontificia Universidad Catolica de Chile
Formulario MAgistral Farmacias Ahumada
Principal Investigator: Cristian Vera-Kellet, MD UDA Dermatologia, Escuela de Medicina, Pontificia Universidad Catolica de Chile
Pontificia Universidad Catolica de Chile
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP