Dexamethasone Irrigation of the Parotid Glands in Primary Sjogren's Syndrome Subjects
- Sjogren's syndrome is an autoimmune disease (where the immune system attacks normal body tissues) that affects the salivary glands. Many people with Sjogren'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 Sjogren'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 Sjogren's syndrome.
- Women between 18 and greater of age who have been diagnosed with primary Sjogren'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.
|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 Sjogren's Syndrome Subjects|
- Change in salivary flow from Day 0 to Day 56. [ Time Frame: 56 days ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
|Contact: Eileen M Pelayo||(301) email@example.com|
|Contact: Ilias G Alevizos, D.M.D.||(301) firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Ilias G Alevizos, D.M.D.||National Institute of Dental and Craniofacial Research (NIDCR)|