Effects of Hydroxychloroquine on Oral Complaints of Sjögren Patients

Xerostomia Clinical Trial

Official title:

Effects of Hydroxychloroquine on Oral Complaints of Sjögren Patients: a Prospective Sample Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00873496
• Other study ID #: EAlpoz 1
• Status: Completed
• Phase: N/A
• First received: March 31, 2009
• Last updated: March 31, 2009
• Start date: January 2005
• Est. completion date: January 2009

Study information

• Verified date: March 2009
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Chronic inflammation that comprises the exocrine glands' function leads to xerophthalmia and xerostomia in Sjögren's syndrome. The oral consequences range widely and they are related to decreased salivary output. Hydroxychloroquine may inhibit cholinesterase activity in salivary glands via interference with antigen processing mechanism, and thus, the investigators' hypothesis was that salivary gland function may be improved if treated with hydroxychloroquine. The effects of hydroxychloroquine on the salivary flow rate, subjective and objective parameters of the patients were also assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients who were recently diagnosed with primary SS according to American-European criteria and who were scheduled for HCQ treatment in Ege University Faculty of Medicine, Department of Rheumatology

Exclusion Criteria:

• Sjögren patients consuming alcohol or tobacco

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sjogren's Syndrome
• Sjögren's Syndrome
• Xerostomia

Intervention

Drug:
• Hydroxychloroquine

Locations

Country	Name	City	State
Turkey	Ege University School of Dentistry	Izmir	Bornova

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Alpöz E, Güneri P, Onder G, Cankaya H, Kabasakal Y, Köse T. The efficacy of Xialine in patients with Sjögren's syndrome: a single-blind, cross-over study. Clin Oral Investig. 2008 Jun;12(2):165-72. Epub 2007 Nov 14. — View Citation

Dawson LJ, Caulfield VL, Stanbury JB, Field AE, Christmas SE, Smith PM. Hydroxychloroquine therapy in patients with primary Sjögren's syndrome may improve salivary gland hypofunction by inhibition of glandular cholinesterase. Rheumatology (Oxford). 2005 A — View Citation

Kruize AA, Hené RJ, Kallenberg CG, van Bijsterveld OP, van der Heide A, Kater L, Bijlsma JW. Hydroxychloroquine treatment for primary Sjögren's syndrome: a two year double blind crossover trial. Ann Rheum Dis. 1993 May;52(5):360-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivary flow rate, objective and subjective clinical oral complaints		2005 Jan-2009 Jan	No