Clinical trial NCT00438048: A Comparison of Orally Pilocarpine and Artificial Saliva in Xerostomy 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary Sjogren
Secondary Sjogren
Xerostomia
Keywords: Pilocarpine
Artificial saliva
Xerostomia
Xerostomy
Primary Sjogren
Secondary Sjogren
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
Collaborators: name: Formulario MAgistral Farmacias Ahumada
First posted: 2007-02-21
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
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.
timeFrame: 12 weeks
Secondary outcomes:
measure: Determine on a subjetive manner wich treatment is better fot patients.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Unidad Docente Asociada Dermatologia. Escuela de MEdicina Pontificia Universidad Catolica de Chile
state: Region Metropolitana
Study officials:
affiliation: UDA Dermatologia, Escuela de Medicina, Pontificia Universidad Catolica de Chile
name: Cristian Vera-Kellet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Sjogren's Syndrome Patients With Oral Pilocarpine: A Randomized, Placebo-Controlled, Dose-Adjustment Study. J Clin Rheumatol. 2004 Aug;10(4):169-77. doi: 10.1097/01.rhu.0000135553.08057.21.
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citation: Solans R, Bosch JA, Selva A, Simeon CP, Fonollosa V, Vilardell M. [Usefulness of oral pilocarpin therapy in the treatment of xerostomia and xerophthalmia in patients with primary Sjogren's syndrome]. Med Clin (Barc). 2004 Feb 28;122(7):253-5. doi: 10.1016/s0025-7753(04)75314-2. Spanish.
citation: 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 Sjogren's syndrome: a randomised 12 week controlled study. Ann Rheum Dis. 2003 Dec;62(12):1204-7. doi: 10.1136/ard.2002.003889.
citation: Wu CH, Hsieh SC, Lee KL, Li KJ, Lu MC, Yu CL. Pilocarpine hydrochloride for the treatment of xerostomia in patients with Sjogren's syndrome in Taiwan--a double-blind, placebo-controlled trial. J Formos Med Assoc. 2006 Oct;105(10):796-803. doi: 10.1016/S0929-6646(09)60266-7.
citation: Brito-Zeron P, Ramos-Casals M, Nardi N, Font J. [Results of the treatment with oral pilocarpine in 100 patients with primary Sjogrens syndrome]. Med Clin (Barc). 2006 Apr 29;126(16):637. doi: 10.1157/13087738. No abstract available. Spanish.
citation: Aframian DJ, Helcer M, Livni D, Markitziu A. Pilocarpine for the treatment of salivary glands' impairment caused by radioiodine therapy for thyroid cancer. Oral Dis. 2006 May;12(3):297-300. doi: 10.1111/j.1601-0825.2005.01195.x.
citation: Aragona P, Di Pietro R, Spinella R, Mobrici M. Conjunctival epithelium improvement after systemic pilocarpine in patients with Sjogren's syndrome. Br J Ophthalmol. 2006 Feb;90(2):166-70. doi: 10.1136/bjo.2005.078865.