Dexamethasone Irrigation of the Parotid Glands in Primary Sjögren's Syndrome Subjects

NCT01316770 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 11009411-D-0094
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Sjögren's syndrome is an autoimmune disease (where the immune system attacks normal body tissues) that affects the salivary glands. Many people with Sjögren'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 Sjögren'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 Sjögren's syndrome. Eligibility: \- Women between 18 and greater of age who have been diagnosed with primary Sjögren'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.

Conditions

Sjögren's Syndrome; Xerostomia

Keywords

Xerostomia; Sjögren's Syndrome; Interventional Study; Sjogren's Syndrome; Dry Mouth

Outcome Measures

Primary Outcomes (1)

• Change in Parotid Salivary Flow From Baseline (Day 0) to Day 56.

  Saliva flow rate was determined by weighing the saliva flow collected separately from each parotid (dexamethasone irrigated and placebo irrigated parotid) within a participant and dividing by collection time. Saliva was collected using a Teflon collection cup placed over the parotid duct orifice and held in place by slight negative pressure. Collection time was 1 minute. The primary outcome measure is looking at change from baseline at Study Day 56 and not the flow at any particular time.

  Baseline (Study Day 0) to Study Day 56

Secondary Outcomes (46)

• Change in Parotid Salivary Flow From Baseline (Study Day 0) to Study Day 14.

  Baseline to 14 days post-baseline

• Change in Parotid Salivary Flow From Baseline (Day 0) to Day 28.

  Baseline to 28 days post-baseline

• Change in Parotid Salivary Flow From Baseline (Day 0) to Day 42.

  Baseline to 42 days post-baseline

• Patient Dry Mouth Questionnaire. Question: Do You Have More Difficulty Chewing Your Food Since Starting the Study?

  Baseline (Study Day 0) through Study Day 56

• Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why?

  Baseline (Study Day 0) through Study Day 56

Study Arms (2)

Placebo Parotid Irrigation

PLACEBO COMPARATOR

Within-Subject, Double-Blind, Placebo-Controlled Study. This parotid gland is irrigated with saline (placebo). { UPDATE: drug(generic) was administered at what time pt, dose of drug, route administration, frequency}

Drug: Placebo Parotid Irrigation

Dexamethasone Parotid Irrigation

EXPERIMENTAL

Within-Subject, Double-Blind, Placebo-Controlled Study. This parotid gland is irrigated with dexamethasone {UPDATE: drug (generic) was administered at what time pt, dose of drug, route administration, frequency}

Drug: Dexamethasone Parotid Irrigation

Interventions

Dexamethasone Parotid Irrigation DRUG

Irrigation of the parotid gland from one side of the mouth with dexamethasone.

Also known as: Placebo Parotid Irrigation

Dexamethasone Parotid Irrigation

Placebo Parotid Irrigation DRUG

Irrigation of the parotid gland on the opposite side of the mouth with placebo saline.

Placebo Parotid Irrigation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) Sjögren's Syndrome Clinic
• Minor salivary gland (MSG) 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.

You may not qualify if:

• 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 Sjögren'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.

Sponsors & Collaborators

• National Institute of Dental and Craniofacial Research (NIDCR): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Izumi M, Eguchi K, Nakamura H, Takagi Y, Kawabe Y, Nakamura T. Corticosteroid irrigation of parotid gland for treatment of xerostomia in patients with Sjogren's syndrome. Ann Rheum Dis. 1998 Aug;57(8):464-9. doi: 10.1136/ard.57.8.464.

  PMID: 9797551 BACKGROUND

• Takagi Y, Katayama I, Tashiro S, Nakamura T. Parotid irrigation and cevimeline gargle for treatment of xerostomia in Sjogren's syndrome. J Rheumatol. 2008 Nov;35(11):2289-91. doi: 10.3899/jrheum.080370. No abstract available.

  PMID: 19004065 BACKGROUND

• Manor W. A clinical learning experience in discharge planning. Nurse Educ. 1991 Nov-Dec;16(6):35. No abstract available.

  PMID: 1754137 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Sjogren's Syndrome; Xerostomia

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Ilias Alevizos
• Organization: NIDCR/NIH

alevizosi@mail.nih.gov

3014966207

Study Officials

• Ilias G Alevizos, D.M.D.

  National Institute of Dental and Craniofacial Research (NIDCR)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2011
• First Posted: March 16, 2011
• Study Start: May 1, 2011
• Primary Completion: April 17, 2017
• Study Completion: April 17, 2017
• Last Updated: November 2, 2018
• Results First Posted: November 2, 2018

Record last verified: 2018-11

Locations

US (1)