A Comparison of Orally Pilocarpine and Artificial Saliva in Xerostomy Treatment

This study has been completed.
Sponsor:
Collaborator:
Formulario MAgistral Farmacias Ahumada
Information provided by:
Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier:
NCT00438048
First received: February 20, 2007
Last updated: May 21, 2008
Last verified: May 2008
  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
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

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 ] [ Designated as safety issue: Yes ]

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

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 Names:
  • pilocarpine
  • Artificial saliva
Drug: Artificial Saliva
5ml 3 times daily
Other Names:
  • pilocarpine
  • Artificial saliva

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: February 20, 2007
Last Updated: May 21, 2008
Health Authority: Chile: Instituto de Salud Pública de Chile

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
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Dry Eye Syndromes
Eye Diseases
Immune System Diseases
Joint Diseases
Lacrimal Apparatus Diseases
Mouth Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Stomatognathic Diseases
Pilocarpine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Miotics
Molecular Mechanisms of Pharmacological Action
Muscarinic Agonists
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 30, 2014