A Comparison of Orally Pilocarpine and Artificial Saliva in Xerostomy Treatment
Information source: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Primary Sjogren; Secondary Sjogren; Xerostomia
Intervention: pilocarpine (Procedure); Artificial Saliva (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Pontificia Universidad Catolica de Chile Official(s) and/or principal investigator(s): Cristian Vera-Kellet, MD, Principal Investigator, Affiliation: UDA Dermatologia, Escuela de Medicina, Pontificia Universidad Catolica de Chile
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.
Clinical Details
Official title: Xerostomy Treatment in Patients With Sjogren's Syndrome in Chile :A Double Blind Control Trial Comparing Orally Pilocarpine Drops and Artificial Saliva
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: Determine on a subjetive manner wich treatment is better fot patients.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Unidad Docente Asociada Dermatologia. Escuela de MEdicina Pontificia Universidad Catolica de Chile, Santiago, Region Metropolitana, Chile
Additional Information
Related publications: Papas AS, Sherrer YS, Charney M, Golden HE, Medsger TA Jr, Walsh BT, Trivedi M, Goldlust B, Gallagher SC. Successful Treatment of Dry Mouth and Dry Eye Symptoms in Sjögren's Syndrome Patients With Oral Pilocarpine: A Randomized, Placebo-Controlled, Dose-Adjustment Study. J Clin Rheumatol. 2004 Aug;10(4):169-77. Al-Hashimi I. Xerostomia secondary to Sjögren's syndrome in the elderly: recognition and management. Drugs Aging. 2005;22(11):887-99. Review. Masters KJ. Pilocarpine treatment of xerostomia induced by psychoactive medications. Am J Psychiatry. 2005 May;162(5):1023. Götrick B, Akerman S, Ericson D, Torstenson R, Tobin G. Oral pilocarpine for treatment of opioid-induced oral dryness in healthy adults. J Dent Res. 2004 May;83(5):393-7. Hendrickson RG, Morocco AP, Greenberg MI. Pilocarpine toxicity and the treatment of xerostomia. J Emerg Med. 2004 May;26(4):429-32. Solans R, Bosch JA, Selva A, Simeón CP, Fonollosa V, Vilardell M. [Usefulness of oral pilocarpin therapy in the treatment of xerostomia and xerophthalmia in patients with primary Sjögren's syndrome]. Med Clin (Barc). 2004 Feb 28;122(7):253-5. Spanish. Tsifetaki N, Kitsos G, Paschides CA, Alamanos Y, Eftaxias V, Voulgari PV, Psilas K, Drosos AA. Oral pilocarpine for the treatment of ocular symptoms in patients with Sjögren's syndrome: a randomised 12 week controlled study. Ann Rheum Dis. 2003 Dec;62(12):1204-7.
Starting date: November 2006
Last updated: May 21, 2008
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