A Comparison of Orally Pilocarpine and Artificial Saliva in Xerostomy Treatment - Full Text View

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 IV

MedlinePlus related topics:

Sjogren's Syndrome

ChemIDplus related topics:

Pilocarpine Pilocarpine hydrochloride Pilocarpine nitrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Xerostomy Treatment in Patients With Sjogren's Syndrome in Chile :A Double Blind Control Trial Comparing Orally Pilocarpine Drops and Artificial Saliva

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
a,b: Active Comparator 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 Drug: Artificial Saliva 5ml 3 times daily

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00438048

Locations


Chile, Region Metropolitana
	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 of Results:

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.

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. Spanish. No abstract available.

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.

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.

Other 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 Sjogren's Syndrome Patients With Oral Pilocarpine: A Randomized, Placebo-Controlled, Dose-Adjustment Study. J Clin Rheumatol. 2004 Aug;10(4):169-177.

Al-Hashimi I. Xerostomia secondary to Sjogren'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. No abstract available.

Gotrick 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, 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. 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 Sjogren's syndrome: a randomised 12 week controlled study. Ann Rheum Dis. 2003 Dec;62(12):1204-7.

Responsible Party:	Pontificia Universidad Católica de Chile ( Cristian Vera Kellet )
Study ID Numbers:	CAVK-130108245-1
First Received:	February 20, 2007
Last Updated:	May 21, 2008
ClinicalTrials.gov Identifier:	NCT00438048
Health Authority:	Chile: Instituto de Salud Publica de Chile

Keywords provided by Pontificia Universidad Catolica de Chile:

Pilocarpine

Artificial saliva

Xerostomia

Xerostomy

Primary Sjogren

Secondary Sjogren

Study placed in the following topic categories:

Mouth Diseases

Autoimmune Diseases

Eye Diseases

Joint Diseases

Arthritis, Rheumatoid

Lacrimal Apparatus Diseases

Dry Eye Syndromes

Rheumatic Diseases

Xerostomia

Musculoskeletal Diseases

Arthritis

Connective Tissue Diseases

Neoplasm Metastasis

Sjogren's Syndrome

Pilocarpine

Stomatognathic Diseases

Salivary Gland Diseases

Additional relevant MeSH terms:

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Immune System Diseases

Cholinergic Agonists

Miotics

Physiological Effects of Drugs

Cholinergic Agents

Pharmacologic Actions

Neoplastic Processes

Neoplasms

Pathologic Processes

Autonomic Agents

Muscarinic Agonists

Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	Pontificia Universidad Catolica de Chile Formulario MAgistral Farmacias Ahumada
Information provided by:	Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier:	NCT00438048