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Trial record 1 of 4 for:    Sj�gren's Syndrome
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Dexamethasone Irrigation of the Parotid Glands in Primary Sj(SqrRoot)(Delta)Gren s Syndrome Subjects

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) ) Identifier:
First received: March 15, 2011
Last updated: September 9, 2016
Last verified: April 2016


- 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.


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


- 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.


  • 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.

Condition Intervention Phase
Sj(SqrRoot)(Delta)Gren s Syndrome
Drug: Dexamethasone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Change in salivary flow from Day 0 to Day 56. [ Time Frame: 56 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in focus score on biopsy. [ Time Frame: 56 days ] [ Designated as safety issue: No ]
  • Change in salivary flow from Day 0 to study Days 14, 28, 42 and 56. [ Time Frame: 56 days ] [ Designated as safety issue: No ]
  • Change in responses on Patient Dry Mouth Questionnaire. [ Time Frame: 56 days ] [ Designated as safety issue: No ]
  • Change in other assessments of salivary function. [ Time Frame: 56 days ] [ Designated as safety issue: No ]
  • Change in laboratory measures of inflammation. [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]
  • Change in frequency of AEs. [ Time Frame: 56 days ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: February 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
  • 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.


  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01316770

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
Principal Investigator: Ilias G Alevizos, D.M.D. National Institute of Dental and Craniofacial Research (NIDCR)
  More Information

Additional Information:
Responsible Party: National Institute of Dental and Craniofacial Research (NIDCR) Identifier: NCT01316770     History of Changes
Other Study ID Numbers: 110094  11-D-0094 
Study First Received: March 15, 2011
Last Updated: September 9, 2016
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Sj(SqrRoot)(Delta)gren s Syndrome
Interventional Study
Sjogren Syndrome
Dry Mouth

Additional relevant MeSH terms:
Pathologic Processes
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on December 02, 2016