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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01316770
• Date of registration: 15/03/2011
• Prospective Registration: Yes
• Primary sponsor: National Institute of Dental and Craniofacial Research (NIDCR)
• Public title: Dexamethasone Irrigation of the Parotid Glands in Primary Sjögren's Syndrome Subjects
• Scientific title: A Randomized Within-Subject, Double-Blind, Placebo-Controlled Study of Dexamethasone Irrigation of the Parotid Glands in Primary Sjögren's Syndrome Subjects
• Date of first enrolment: May 1, 2011
• Target sample size: 14
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01316770
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Ilias G Alevizos, D.M.D.
• Affiliation: National Institute of Dental and Craniofacial Research (NIDCR)

Key inclusion & exclusion 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)
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.

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 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.

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Sjögren's Syndrome

Xerostomia

Intervention(s)

Drug: Dexamethasone Parotid Irrigation

Drug: Placebo Parotid Irrigation

Primary Outcome(s)

Change in Parotid Salivary Flow From Baseline (Day 0) to Day 56. [Time Frame: Baseline (Study Day 0) to Study Day 56]

Secondary Outcome(s)

Patient Dry Mouth Questionnaire: Do You Use Anything to Keep Your Mouth Moist? [Time Frame: Baseline (Study Day 0) through Study Day 56]

Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: [Time Frame: Baseline (Study Day 0) through Study Day 56]

Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 14, Ordinal Scale [Time Frame: Baseline (Study Day 0) to Study Day 14]

Change in Parotid Salivary Flow From Baseline (Study Day 0) to Study Day 14. [Time Frame: Baseline to 14 days post-baseline]

Change in Parotid Salivary Flow From Baseline (Day 0) to Day 28. [Time Frame: Baseline to 28 days post-baseline]

Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? [Time Frame: Baseline (Study Day 0) through Study Day 56]

Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? [Time Frame: Baseline (Study Day 0) through Study Day 56]

Patient Dry Mouth Questionnaire: Have You Experienced Any Changes in Your Sense of Taste Since Starting the Study? [Time Frame: Baseline (Study Day 0) through Study Day 56]

Sjögren's Disease Activity Index: Compared With Baseline, do You Consider Your Patient Presents a Systemic Flare of the Participant's pSS (Primary Sjögren's Syndrome): [Time Frame: Baseline (Study Day 0) through Study Day 56]

Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: [Time Frame: Baseline (Study Day 0) through Study Day 56]

Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 42, Ordinal Scale [Time Frame: Baseline (Study Day 0) to Study Day 42]

Patient Dry Mouth Questionnaire. Question: Have You Experienced Any Changes in Your Sense of Smell Since Starting the Study? [Time Frame: Baseline (Study Day 0) through Study Day 56]

Shift Table of the Change in Parotid Technetium Scan at Study Day 56 From Stage II Screening Visit [Time Frame: Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56]

Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? [Time Frame: Baseline (Study Day 0) through Study Day 56]

Change in Parotid Salivary Flow From Baseline (Day 0) to Day 42. [Time Frame: Baseline to 42 days post-baseline]

Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? [Time Frame: Baseline (Study Day 0) through Study Day 56]

Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? [Time Frame: Baseline (Study Day 0) through Study Day 56]

Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? [Time Frame: Baseline (Study Day 0) through Study Day 56]

Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Ordinal Numeric Scale) [Time Frame: Baseline (Study Day 0) through Study Day 56]

Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 14 , Ordinal Scores [Time Frame: Baseline (Study Day 0) through Study Day 14]

Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? [Time Frame: Baseline (Study Day 0) through Study Day 56]

Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: [Time Frame: Baseline (Study Day 0) through Study Day 56]

Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? [Time Frame: Baseline (Study Day 0) through Study Day 56]

Summary Statistics of Technetium Scans [Time Frame: Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56]

Patient Dry Mouth Questionnaire. Question: Do You Have More Difficulty Chewing Your Food Since Starting the Study? [Time Frame: Baseline (Study Day 0) through Study Day 56]

Patient Dry Mouth Questionnaire: Do You Have More Difficulty Swallowing Dry Foods Without Additional Liquids Since Starting the Study? [Time Frame: Baseline (Study Day 0) through Study Day 56]

Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? [Time Frame: Baseline (Study Day 0) through Study Day 56]

Patient Dry Mouth Questionnaire: Do You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study? [Time Frame: Baseline (Study Day 0) through Study Day 56]

Patient Dry Mouth Questionnaire: If You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study, Specify: [Time Frame: Baseline (Study Day 0) through Study Day 56]

Shift Table of Focus Scores From Stage II Screening to Study Day 56 [Time Frame: Stage II Screening (within 6 wks before baseline) through 56 days post-baseline]

Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: [Time Frame: Baseline (Study Day 0) through Study Day 56]

Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 28, Ordinal Scale [Time Frame: Baseline (Study Day 0) to Study Day 28]

Sjögren's Disease Activity Index: Indicate the Level of Disease Activity in This Patient, Taking Into Account the Symptoms of Your Patient's (Dryness, Pain, Physical and Mental Fatigue), Ordinal Scores [Time Frame: Baseline (Study Day 0) through Study Day 56]

Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 56 , Ordinal Scores [Time Frame: Baseline (Study Day 0) through Study Day 56]

Summary Statistics of MRI Scans [Time Frame: Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56]

Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit [Time Frame: Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56]

Sjögren's Disease Activity Index Shift Table. Question: Do You Consider Your Patient in a Satisfactory State of "Minimal Disease Activity? The Shift Table Data Was Not Rich Enough to Perform McNemar's Test on the Shift Tables of Any of the Study Days. [Time Frame: Baseline (Study Day 0) through Study Day 56]

Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) [Time Frame: Baseline (Study Day 0) through Study Day 56]

Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale [Time Frame: Baseline (Study Day 0) to Study Day 56]

Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 56, Ordinal Scale [Time Frame: Baseline (Study Day 0) to Study Day 56]

Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 42 , Ordinal Scores [Time Frame: Baseline (Study Day 0) through Study Day 42]

Summary Statistics of Focus Score [Time Frame: Stage II screening (within 6 wks before baseline) through 56 days post-baseline]

Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? [Time Frame: Baseline (Study Day 0) through Study Day 56]

Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? [Time Frame: Baseline (Study Day 0) through Study Day 56]

Sjögren's Disease Activity Index: Do You Consider Your Patient in a Satisfactory State of 'Minimal Disease Activity'? [Time Frame: Baseline (Study Day 0) through Study Day 56]

Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 28 , Ordinal Scores [Time Frame: Baseline (Study Day 0) through Study Day 28]

Secondary ID(s)

110094

11-D-0094

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 02/11/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01316770