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Effects of Hydroxychloroquine on Oral Complaints of Sjögren Patients

This study has been completed.
Sponsor:
Information provided by:
Ege University
ClinicalTrials.gov Identifier:
NCT00873496
First received: March 31, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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 Intervention
Sjögren's Syndrome
Xerostomia
 Drug: Hydroxychloroquine

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effects of Hydroxychloroquine on Oral Complaints of Sjögren Patients: a Prospective Sample Study.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ege University:

Primary Outcome Measures:
  • Salivary flow rate, objective and subjective clinical oral complaints [ Time Frame: 2005 Jan-2009 Jan ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: January 2005
Study Completion Date: January 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Sjögren
Pre and post treatment establishment of salivary flow rate, objective and subjective clinical oral complications' severity of the patients using hydroxychloroquine
 Drug: Hydroxychloroquine

  Eligibility

Genders 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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00873496

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

Publications:

Responsible Party: Esin Alpoz, Ege University School of Dentistry
ClinicalTrials.gov Identifier: NCT00873496     History of Changes
Other Study ID Numbers: EAlpoz 1
Study First Received: March 31, 2009
Last Updated: March 31, 2009
Health Authority: Turkey: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 16, 2013