Effects of Hydroxychloroquine on Oral Complaints of Sjögren Patients

Sponsor

Ege University (Other)

Overall Status

Completed

CT.gov ID

NCT00873496

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sjögren's Syndrome Xerostomia	Drug: Hydroxychloroquine

Study Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jan 1, 2005

Actual Primary Completion Date :

Oct 1, 2008

Actual Study Completion Date :

Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Sjögren Pre and post treatment establishment of salivary flow rate, objective and subjective clinical oral complications' severity of the patients using hydroxychloroquine	Drug: Hydroxychloroquine

Arm

Intervention/Treatment

Sjögren

Pre and post treatment establishment of salivary flow rate, objective and subjective clinical oral complications' severity of the patients using hydroxychloroquine

Drug: Hydroxychloroquine

Outcome Measures

Primary Outcome Measures

Salivary flow rate, objective and subjective clinical oral complaints [2005 Jan-2009 Jan]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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