Effects of Hydroxychloroquine on Oral Complaints of Sjögren Patients

NCT ID: NCT00873496

Last Updated: 2009-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Study Completion Date

2009-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sjögren's Syndrome Xerostomia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Sjögren

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

Hydroxychloroquine

Intervention Type DRUG

Interventions

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Hydroxychloroquine

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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Ege University School of Dentistry

Principal Investigators

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Esin Alpoz

Role: STUDY_DIRECTOR

Ege University School of Dentistry

Locations

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Ege University School of Dentistry

Izmir, Bornova, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Alpoz E, Guneri P, Onder G, Cankaya H, Kabasakal Y, Kose T. The efficacy of Xialine in patients with Sjogren's syndrome: a single-blind, cross-over study. Clin Oral Investig. 2008 Jun;12(2):165-72. doi: 10.1007/s00784-007-0159-3. Epub 2007 Nov 14.

Reference Type BACKGROUND
PMID: 18000691 (View on PubMed)

Kruize AA, Hene RJ, Kallenberg CG, van Bijsterveld OP, van der Heide A, Kater L, Bijlsma JW. Hydroxychloroquine treatment for primary Sjogren's syndrome: a two year double blind crossover trial. Ann Rheum Dis. 1993 May;52(5):360-4. doi: 10.1136/ard.52.5.360.

Reference Type RESULT
PMID: 8323383 (View on PubMed)

Dawson LJ, Caulfield VL, Stanbury JB, Field AE, Christmas SE, Smith PM. Hydroxychloroquine therapy in patients with primary Sjogren's syndrome may improve salivary gland hypofunction by inhibition of glandular cholinesterase. Rheumatology (Oxford). 2005 Apr;44(4):449-55. doi: 10.1093/rheumatology/keh506. Epub 2004 Dec 8.

Reference Type RESULT
PMID: 15590764 (View on PubMed)

Other Identifiers

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EAlpoz 1

Identifier Type: -

Identifier Source: org_study_id

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