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A Comparison of Orally Pilocarpine and Artificial Saliva in Xerostomy Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00438048
First Posted: February 21, 2007
Last Update Posted: May 22, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Formulario MAgistral Farmacias Ahumada
Information provided by:
Pontificia Universidad Catolica de Chile
  Purpose
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.

Condition Intervention Phase
Primary Sjogren Secondary Sjogren Xerostomia Procedure: pilocarpine Drug: Artificial Saliva Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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

Resource links provided by NLM:


Further study details as provided by Pontificia Universidad Catolica de Chile:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Determine on a subjetive manner wich treatment is better fot patients. [ Time Frame: 12 weeks ]

Enrollment: 76
Study Start Date: November 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: a,b
Compare Pilocarpine and Artificial saliva
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

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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00438048


Locations
Chile
Unidad Docente Asociada Dermatologia. Escuela de MEdicina Pontificia Universidad Catolica de Chile
Santiago, Region Metropolitana, Chile
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Formulario MAgistral Farmacias Ahumada
Investigators
Principal Investigator: Cristian Vera-Kellet, MD UDA Dermatologia, Escuela de Medicina, Pontificia Universidad Catolica de Chile
  More Information

Publications:

Responsible Party: Cristian Vera Kellet, Pontificia Universidad Católica de Chile
ClinicalTrials.gov Identifier: NCT00438048     History of Changes
Other Study ID Numbers: CAVK-130108245-1
First Submitted: February 20, 2007
First Posted: February 21, 2007
Last Update Posted: May 22, 2008
Last Verified: May 2008

Keywords provided by Pontificia Universidad Catolica de Chile:
Pilocarpine
Artificial saliva
Xerostomia
Xerostomy
Primary Sjogren
Secondary Sjogren

Additional relevant MeSH terms:
Sjogren's Syndrome
Xerostomia
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pilocarpine
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action