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

Sponsor:	Pontificia Universidad Catolica de Chile
Collaborator:	Formulario MAgistral Farmacias Ahumada
Information provided by:	Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier:	NCT00438048

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

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

Resource links provided by NLM:

MedlinePlus related topics: Sjogren's Syndrome

Drug Information available for: Pilocarpine hydrochloride Pilocarpine Pilocarpine nitrate

U.S. FDA Resources

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:

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.

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
Study First Received:	February 20, 2007
Last Updated:	May 21, 2008
ClinicalTrials.gov Identifier:	NCT00438048 History of Changes
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

Additional relevant MeSH terms:

Mouth Diseases
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Agonists
Physiological Effects of Drugs
Arthritis, Rheumatoid
Lacrimal Apparatus Diseases
Dry Eye Syndromes
Cholinergic Agents
Neoplastic Processes
Pathologic Processes
Musculoskeletal Diseases
Arthritis
Neoplasm Metastasis
Connective Tissue Diseases

Pilocarpine
Salivary Gland Diseases
Autoimmune Diseases
Immune System Diseases
Joint Diseases
Eye Diseases
Miotics
Rheumatic Diseases
Pharmacologic Actions
Xerostomia
Neoplasms
Autonomic Agents
Muscarinic Agonists
Sjogren's Syndrome
Stomatognathic Diseases

ClinicalTrials.gov processed this record on February 08, 2010