Sjögren's SyndromeNCT00873496
Effects of Hydroxychloroquine on Oral Complaints of Sjögren Patients
An observational study of Sjögren's Syndrome and Xerostomia, run by Ege University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Sjögren's Syndrome, Xerostomia
- What is being tested?
- Hydroxychloroquine
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2005to Jan 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study group consisted of 30 female patients recently diagnosed as Sjögren's syndrome.
Who may be able to join
- 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
Who cannot join
- Sjögren patients consuming alcohol or tobacco
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University School of Dentistry
Izmir, Bornova, 35100
About this study
Official title: Effects of Hydroxychloroquine on Oral Complaints of Sjögren Patients: a Prospective Sample Study.
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.
- Conditions
- Sjögren's Syndrome, Xerostomia
- Being tested
- Hydroxychloroquine
- Keywords
- Sjögren's Syndrome, hyposalivation, mouth dryness, complications
- Medical subject headings
- Sjogren's Syndrome, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sjögren | Pre and post treatment establishment of salivary flow rate, objective and subjective clinical oral complications' severity of the patients using hydroxychloroquine Receives: Drug: Hydroxychloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary flow rate, objective and subjective clinical oral complaints
Measured: 2005 Jan-2009 Jan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2009 (estimated)
- Study startJan 2005
- Primary completionOct 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sjögren's SyndromeStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Investigators
- Esin Alpoz, Study director, Ege University School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873496
- Sponsor's protocol ID
- EAlpoz 1
- Status last verified
- Mar 2009
- First submitted
- 31 Mar 2009
- Last updated
- 1 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18000691Kruize 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.
PubMed 8323383Dawson 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.
PubMed 15590764
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hydroxychloroquine on Oral Complaints of Sjögren Patients: a Prospective Sample Study.
- ClinicalTrials.gov ID
- NCT00873496
- Acronym / sponsor ID
- EAlpoz 1
- Conditions
- Sjögren's Syndrome, Xerostomia
- Keywords
- Sjögren's Syndrome, hyposalivation, mouth dryness, complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 1 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sjögren | – | Drug: HydroxychloroquinePre and post treatment establishment of salivary flow rate, objective and subjective clinical oral complications' severity of the patients using hydroxychloroquine |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study group consisted of 30 female patients recently diagnosed as Sjögren's syndrome.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Sjögren patients consuming alcohol or tobacco
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxychloroquine | Drug | Sjögren |
Primary outcome
Salivary flow rate, objective and subjective clinical oral complaints
Time frame: 2005 Jan-2009 Jan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2009.
- Background: PubMed 18000691Alpoz 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.
- Results publication: PubMed 8323383Kruize 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.
- Results publication: PubMed 15590764Dawson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esin Alpoz study director
Ege University School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sjögren's Syndrome and Xerostomia, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary flow rate, objective and subjective clinical oral complaints (time frame: 2005 Jan-2009 Jan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00873496, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2009.