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Protocol Details

A Randomized Within-Subject, Double-Blind, Placebo-Controlled Study of Dexamethasone Irrigation of the Parotid Glands in Primary Sj(SqrRoot)(Delta)gren's Syndrome Subjects

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

11-D-0094

Sponsoring Institute

National Institute of Dental And Craniofacial Research (NIDCR)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Male;
Children

Special Instructions

Currently Not Provided

Keywords

Xerostomia;
Sj(SqrRoot)(Delta)gren s Syndrome;
Interventional Study

Recruitment Keyword(s)

Sjogren Syndrome;
Dry Mouth

Condition(s)

Sj(SqrRoot)(Delta)gren s Syndrome;
Xerostomia

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Drug: Dexamethasone

Supporting Site

National Institute of Dental and Craniofacial Research

Background:

- Sj(SqrRoot)(Delta)gren s syndrome is an autoimmune disease (where the immune system attacks normal body tissues) that affects the salivary glands. Many people with Sj(SqrRoot)(Delta)gren s syndrome are not able to make enough saliva because their salivary glands are inflamed. The dry mouth that results can interfere with daily activities and can lead to dental cavities, mouth sores, and infections. Injections of corticosteroids into the parotid glands can improve saliva production in people with to Sj(SqrRoot)(Delta)gren s syndrome, but current treatment practices may provide only temporary relief. Researchers are interested in studying the effectiveness of stronger corticosteroid injections (using dexamethasone) to determine how the corticosteroid treatment actually works.

Objectives:

- To evaluate the effectiveness and mechanics of dexamethasone injections to improve saliva production in individuals with primary Sj(SqrRoot)(Delta)gren s syndrome.

Eligibility:

- Women between 18 and greater of age who have been diagnosed with primary Sj(SqrRoot)(Delta)gren s syndrome, and have had a biopsy of the minor salivary glands in the past 5 years that shows a moderate level of inflammation.

Design:

- Participants will be screened with a full medical history and physical examination, blood and urine tests, and salivary gland biopsies. Participants will also be screened with tests of saliva flow production and evaluation of the salivary ducts and glands, and will complete questionnaires about dry mouth symptoms.

- At the first treatment visit, participants will receive an injection of dexamethasone into one parotid gland and an injection of saline into the other gland. After the injections, participants will provide a blood sample to test the level of dexamethasone in the blood.

- Two weeks after the first treatment, participants will return for an evaluation visit to have saliva flow rate measurements taken, and will complete a questionnaire about dry mouth symptoms.

- Four weeks after the first treatment, participants will have a second treatment for each parotid gland, with the same tests and questionnaires as before.

- Participants will have additional evaluation visits 6 and 8 weeks after the first treatment visit, with a followup telephone call approximately 6 weeks after the last dexamethasone treatment visit.

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Eligibility

INCLUSION CRITERIA:

- Female gender and age 18 and greater.

- Diagnosed with primary SS in Protocol 84-D-0056.

- Stimulated salivary flow of at least 0.01 mL/min from each parotid gland, using the standard operating procedure (SOP) for the National Institute of Dental and Craniofacial Research (NIDCR) Molecular Physiology and Therapeutics Branch (MPTB) Sjogren s Syndrome Clinic

-Minor salivary gland biopsy with a focus score of greater than or equal to 1 obtained 0 to 7 years prior to study enrollment. Biopsies from outside of the National Institutes of Health (NIH) must be reviewed by the NIH Pathology Department. An MSG biopsy will be required for the following situations:

- The last biopsy was obtained before the use of rituximab.

- The last biopsy was obtained before the use of immunosuppressants, biologics, or disease-modifying antirheumatic drugs for more than 3 months.

- The last biopsy was obtained before the use of systemic corticosteroids (for more than 2 weeks or for shorter periods at doses of more than 0.5 mg/kg) or local parotid corticosteroids. The use of topical or intra-articular/periarticular corticosteroids will not require a repeat biopsy.

- For women of childbearing potential, use of, or willingness to use, an effective method of birth control during the study. Effective methods include abstinence, history of hysterectomy, tubal ligation, intrauterine device, licensed hormonal methods, condoms, diaphragm, and cervical cap.

- Ability to provide written informed consent prior to entry in the study.

EXCLUSION CRITERIA:

- History of lymphoma.

- History of mycosis, aspergillosis, or other deep fungal infection of the parotid gland.

- History of salivary gland malignancy (primary or metastatic to the salivary gland).

- History of secondary Sj(SqrRoot)(Delta)gren s syndrome.

- Parotid infection that does not resolve at least 4 weeks before the start of the Screening Period.

- Any active viral infection that does not resolve by the start of the Screening Period.

- Pregnancy or lactation.

- Use of biologics within 3 months of the start of the Screening Period.

- Any experimental therapy within 3 months before the start of the Screening Period.

- Use of immunosuppressants such as methotrexate, leflunomide, azathioprine, cyclophosphamide, systemic cyclosporine, or systemic corticosteroids within 3 months prior to the start of the Screening Period.

-Use of inhaled corticosteroids within 3 months prior to the start of the Screening Period.

- Use of antimalarials and regular use of NSAIDs unless the dose has been stable (or decreased) for at least 2 months.

- Inability to discontinue the use of saliva stimulants such as pilocarpine and cevimeline for 24 hours before each study visit.

- Parotid intraductal irrigation or instillation with steroids within the past year.

- Use of rituximab within 6 months prior to the start of the Screening Period.

- Allergy to steroids or technetium, or any components of the formulations.

- Current use of warfarin or heparin.

- History of bleeding disorder.

- Both severe atrophy and fibrosis of the MSG noted on the pathology report of the MSG biopsy.

- Inability to comply with protocol procedures and the number of required visits.

- Inability to cannulate one or both parotid glands.

- Parotid fill volume less than 0.5 mL in one or both parotid glands.

- Significant concurrent medical condition or other circumstances that, in the opinion of the principal investigator, could affect the subject s ability to tolerate or complete the study.

- Unable to understand written English for completion of study questionnaires.


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Citations:

Izumi M, Eguchi K, Nakamura H, Takagi Y, Kawabe Y, Nakamura T. Corticosteroid irrigation of parotid gland for treatment of xerostomia in patients with Sj(SqrRoot)(Delta)gren's syndrome. Ann Rheum Dis. 1998 Aug;57(8):464-9.

Takagi Y, Katayama I, Tashiro S, Nakamura T. Parotid irrigation and cevimeline gargle for treatment of xerostomia in Sj(SqrRoot)(Delta)gren's syndrome. J Rheumatol. 2008 Nov;35(11):2289-91.

Vitali C, Bombardieri S, Jonsson R, Moutsopoulos HM, Alexander EL, Carsons SE, Daniels TE, Fox PC, Fox RI, Kassan SS, Pillemer SR, Talal N, Weisman MH; European Study Group on Classification Criteria for Sj(SqrRoot)(Delta)gren's Syndrome. Classification criteria for Sj(SqrRoot)(Delta)gren's syndrome: a revised version of the European criteria proposed by the American-European Consensus Group. Ann Rheum Dis. 2002 Jun;61(6):554-8.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Ilias G. Alevizos, D.M.D.
National Institute of Dental And Craniofacial Research (NIDCR)
BG 10 RM 1N110
10 CENTER DR
BETHESDA MD 20814
(301) 496-6207
alevizosi@mail.nih.gov

Eileen M. Pelayo
National Institute of Dental And Craniofacial Research (NIDCR)
National Institutes of Health
Building 10
Room 1N110
10 Center Drive
Bethesda, Maryland 20892
(301) 594-3097
pelayoem@mail.nih.gov

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT01316770

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