Dexamethasone Irrigation of the Parotid Glands in Primary Sj(SqrRoot)(Delta)Gren s Syndrome Subjects

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) )
ClinicalTrials.gov Identifier:
NCT01316770
First received: March 15, 2011
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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.

Condition Intervention Phase
Sj(SqrRoot)(Delta)Gren s Syndrome
Xerostomia
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 ]

Estimated Enrollment: 20
Study Start Date: February 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Dexamethasone
    N/A
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • 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.
  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 ClinicalTrials.gov identifier: NCT01316770

Contacts
Contact: Eileen M Pelayo (301) 594-3097 pelayoem@mail.nih.gov
Contact: Ilias G Alevizos, D.M.D. (301) 496-6207 alevizosi@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Ilias G Alevizos, D.M.D. National Institute of Dental and Craniofacial Research (NIDCR)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) )
ClinicalTrials.gov Identifier: NCT01316770     History of Changes
Other Study ID Numbers: 110094, 11-D-0094
Study First Received: March 15, 2011
Last Updated: June 26, 2014
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Syndrome
Xerostomia
Disease
Mouth Diseases
Pathologic Processes
Salivary Gland Diseases
Stomatognathic Diseases
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014