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Effects of Hydroxychloroquine on Oral Complaints of Sjögren Patients

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ClinicalTrials.gov Identifier: NCT00873496
Recruitment Status : Completed
First Posted : April 1, 2009
Last Update Posted : April 1, 2009
Information provided by:
Ege University

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
Sjögren's Syndrome Xerostomia Drug: Hydroxychloroquine

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 : January 2005
Primary Completion Date : October 2008
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Salivary flow rate, objective and subjective clinical oral complaints [ Time Frame: 2005 Jan-2009 Jan ]

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study group consisted of 30 female patients recently diagnosed as Sjögren's syndrome.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00873496

Ege University School of Dentistry
Izmir, Bornova, Turkey, 35100
Sponsors and Collaborators
Ege University
Study Director: Esin Alpoz Ege University School of Dentistry

Responsible Party: Esin Alpoz, Ege University School of Dentistry
ClinicalTrials.gov Identifier: NCT00873496     History of Changes
Other Study ID Numbers: EAlpoz 1
First Posted: April 1, 2009    Key Record Dates
Last Update Posted: April 1, 2009
Last Verified: March 2009

Keywords provided by Ege University:
Sjögren's Syndrome
mouth dryness

Additional relevant MeSH terms:
Sjogren's Syndrome
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents