A Comparison of Orally Pilocarpine and Artificial Saliva in Xerostomy Treatment

Xerostomia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00438048
• Other study ID #: CAVK-130108245-1
• Status: Completed
• Phase: Phase 4
• First received: February 20, 2007
• Last updated: May 21, 2008
• Start date: November 2006
• Est. completion date: May 2008

Study information

• Verified date: May 2008
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Instituto de Salud Pública de Chile
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Primary Sjogren
• Secondary Sjogren
• Sjogren's Syndrome
• Xerostomia

Intervention

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

Locations

Country	Name	City	State
Chile	Unidad Docente Asociada Dermatologia. Escuela de MEdicina Pontificia Universidad Catolica de Chile	Santiago	Region Metropolitana

Sponsors (2)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile	Formulario MAgistral Farmacias Ahumada

Country where clinical trial is conducted

Chile, 

References & Publications (11)

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. — View Citation

Al-Hashimi I. Xerostomia secondary to Sjögren's syndrome in the elderly: recognition and management. Drugs Aging. 2005;22(11):887-99. Review. — View 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. — View Citation

Brito-Zerón P, Ramos-Casals M, Nardi N, Font J. [Results of the treatment with oral pilocarpine in 100 patients with primary Sjögrens syndrome]. Med Clin (Barc). 2006 Apr 29;126(16):637. Spanish. — View Citation

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. — View Citation

Hendrickson RG, Morocco AP, Greenberg MI. Pilocarpine toxicity and the treatment of xerostomia. J Emerg Med. 2004 May;26(4):429-32. — View Citation

Masters KJ. Pilocarpine treatment of xerostomia induced by psychoactive medications. Am J Psychiatry. 2005 May;162(5):1023. — View 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 Sjögren's Syndrome Patients With Oral Pilocarpine: A Randomized, Placebo-Controlled, Dose-Adjustment Study. J Clin Rheumatol. 2004 Aug;10(4):169-77. — View Citation

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. — View 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 Sjögren's syndrome: a randomised 12 week controlled study. Ann Rheum Dis. 2003 Dec;62(12):1204-7. — View Citation

Wu CH, Hsieh SC, Lee KL, Li KJ, Lu MC, Yu CL. Pilocarpine hydrochloride for the treatment of xerostomia in patients with Sjögren's syndrome in Taiwan--a double-blind, placebo-controlled trial. J Formos Med Assoc. 2006 Oct;105(10):796-803. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		12 weeks	Yes
Secondary	Determine on a subjetive manner wich treatment is better fot patients.		12 weeks	Yes