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

Sponsor
National Institute of Dental and Craniofacial Research (NIDCR) (NIH)
Overall Status
Terminated
CT.gov ID
NCT01316770
Collaborator
(none)
14
Enrollment
1
Location
2
Arms
71.6
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dexamethasone Parotid Irrigation
  • Drug: Placebo Parotid Irrigation
 Phase 2

Detailed Description

BACKGROUND:

Salivary gland dysfunction is one of the major manifestations of Sjögren's (SS). Although inflammation is thought to play an important role in the exocrinopathy, the correlation between glandular dysfunction and inflammation is limited. Systemic anti-inflammatory therapies tested to date, such as tumor necrosis factor antagonists, have not been effective treatments for SS salivary hypofunction, raising doubts about inflammation being the sole cause of salivary gland dysfunction. However, none of these trials tested whether an anti-inflammatory effect was achieved in glandular tissues.

Studies by Izumi et al found that a limited course of low-dose topical corticosteroid applied to the parotid glands resulted in sustained improvement in saliva production. Unfortunately, these studies did not examine the mechanistic effects of corticosteroids on the major salivary glands. A plausible assumption is that corticosteroids improved salivary gland function by reducing inflammation, although other or associated mechanisms, such as an improved transcellular ion transport in epithelial cells cannot be ruled out. This study aims to study the efficacy of low-dose topical corticosteroid (dexamethasone) irrigation of the parotid gland in reducing salivary dysfunction in subjects with SS, and also to evaluate the effects of treatment on inflammation and other possible mechanistic processes.

PRIMARY OBJECTIVE:
  • To determine whether irrigation of the parotid gland with low-dose topical dexamethasone improves parotid salivary gland flow in SS subjects.
SECONDARY OBJECTIVES:

  • To perform mechanistic studies to determine the mechanisms of action of low-dose topical corticosteroid irrigation of the parotid gland.

  • To assess biomarkers of inflammation and salivary gland dysfunction in SS subjects treated with low-dose topical corticosteroid irrigation of the parotid glands.

  • To assess localized safety of dexamethasone irrigation of the parotid gland, as compared with placebo.

STUDY POPULATION:

The study will enroll up to 20 adult females with primary SS in order to randomize and treat 16 subjects. Key enrollment criterion include a focus score of greater than or equal to 3 on minor salivary gland biopsy in the previous 5 years and measurable stimulated bilateral parotid salivary flow (greater than or equal to 0.01 mL/min per gland). Subjects will be recruited from protocol 84-D-0056, conducted at the National Institutes of Health (NIH).

DESIGN:

This will be a single-site, randomized-within-subject, double-blind, placebo-controlled, phase 2 pilot study in which all subjects receive both active drug (dexamethasone) and placebo (normal saline), thereby acting as their own controls.The study design is doubly-repeated measures; within a subject, measures are repeated in both time and treatment (i.e., one side of mouth receives dexamethasone while the other receives placebo.). After baseline assessment of salivary flow and other measurements of salivary function, subjects will be randomly assigned, in a double-blind fashion, to dexamethasone irrigation of one parotid gland and normal saline irrigation of the other parotid gland. They will undergo a total of 2 treatment sessions, 4 weeks apart (Days 0 and 28). Post-treatment assessments of salivary flow, dry mouth symptoms, and adverse events (AEs) will be performed at specified intervals.

OUTCOME MEASURES:
Primary Endpoint:
  • Change in salivary flow from Day 0 to Day 56.
Secondary Endpoints:

  • Change in focus score on parotid biopsy from Screening to Day 56.

  • Change in salivary flow from Day 0 to study Days 14, 28, 42, and 56.

  • Changes in assessments on the Patient Dry Mouth Questionnaire from Day 0 to study Days 14, 28, 42, and 56.

  • Changes in assessments on the Sj(SqrRoot)(Delta)gren s Disease Activity Index from Day 0 to study Days 14, 28, 42, and 56.

  • Changes in other assessments of salivary function from baseline to study Day 56, including technetium scan of the salivary glands.

  • Changes in laboratory measures of inflammation.

  • Frequency of AEs related to treatment; AE location (body site, right or left), will be recorded and evaluated, as applicable.

Exploratory endpoints

  • Changes in mechanistic endpoints from baseline to study Days 14, 28, 42, and 56.

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized Within-Subject, Double-Blind, Placebo-Controlled Study of Dexamethasone Irrigation of the Parotid Glands in Primary Sjögren's Syndrome Subjects
Study Start Date :
May 1, 2011
Actual Primary Completion Date :
Apr 17, 2017
Actual Study Completion Date :
Apr 17, 2017

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo Parotid Irrigation

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
Irrigation of the parotid gland on the opposite side of the mouth with placebo saline.
Experimental: Dexamethasone Parotid Irrigation

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
Irrigation of the parotid gland from one side of the mouth with dexamethasone.
Other Names:
  • Placebo Parotid Irrigation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Parotid Salivary Flow From Baseline (Day 0) to Day 56. [Baseline (Study Day 0) to Study 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.

    Secondary Outcome Measures

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

      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 hel in place by slight negative pressure. Collection time was 1 minute. The outcome measure is looking at change from baseline at Study Day 14 and not the flow at any particular time.

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

      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 hel in place by slight negative pressure. Collection time was 1 minute. The outcome measure is looking at change from baseline at Study Day 28 and not the flow at any particular time.

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

      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 hel in place by slight negative pressure. Collection time was 1 minute. The outcome measure is looking at change from baseline at Study Day 42 and not the flow at any particular time.

    4. 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]

      The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.

    5. 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]

      The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.

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

      The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.

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

      The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.

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

      The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible.

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

      The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.

    10. 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: [Baseline (Study Day 0) through Study Day 56]

      The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible.

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

      The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.

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

      The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible.

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

      The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes; No; Not sure.

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

      The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes; No; Not sure.

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

      The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: To little; to much; Do not notice it.

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

      The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.

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

      Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56

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

      Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56. The shift table data were not sufficiently distributed to permit analysis with McNemar's test on any of the study days.

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

      Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56. The shift table data were not sufficiently distributed to permit analysis with McNemar's test on Study Days 42 and 56.

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

      Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56

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

      Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56. The shift table data were not sufficiently distributed to permit analysis with McNemar's test on any of the study days.

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

      Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56. The shift table data were not sufficiently distributed to permit analysis with McNemar's test on any of the study days.

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

      Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56

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

      Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56

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

      Ordinal Scale 0:least to 10:greatest level of disease activity

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

      Nominal scale values: Inactive; Low; Moderate; High

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

      Response: Yes or No

    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 [Baseline (Study Day 0) through Study Day 56]

      Ordinal Scale 0: least to 10: greatest level of disease activity.

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

      Nominal Scale: Much better; Better; The same; Worse; Much worse

    30. 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): [Baseline (Study Day 0) through Study Day 56]

      Response: Yes; No

    31. 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. [Baseline (Study Day 0) through Study Day 56]

      Possible Response: Yes or No

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

      Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.

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

      Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.

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

      Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.

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

      Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.

    36. 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 [Baseline (Study Day 0) to Study Day 56]

      Possible response on nominal scale: Inactive; Low; Moderate; High SDAI.

    37. 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 [Baseline (Study Day 0) to Study Day 14]

      Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.

    38. 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 [Baseline (Study Day 0) to Study Day 28]

      Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.

    39. 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 [Baseline (Study Day 0) to Study Day 42]

      Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.

    40. 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 [Baseline (Study Day 0) to Study Day 56]

      Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.

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

      Medical evaluations of MRI Scans. Possible evaluations include: i) Normal; ii) Abnormal, not clinically significant; iii) Abnormal, clinically significant.

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

      Change in the evaluations of the parotid MRI scans at Study Day 56 from Stage II Screening Visit. Possible MRI evaluations at both Baseline and Study Day 56 include: i)Normal; ii) Abnormal, not clinically significant (Abnormal ncs); and iii) Abnormal, clinically significant (Abnormal cs).

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

      Medical evaluations of Technetium Scans. Possible evaluations include: i) Normal; and ii) Abnormal.

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

      Change in the evaluations of the parotid technetium scans at Study Day 56 from Stage II Screening Visit. Possible technetium scan evaluations at both Baseline and Study Day 56 include: Normal; Abnormal.

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

      Focus score is the number of mononuclear cell infiltrates containing at least 50 inflammatory cells in a 4 mm² glandular section. Focus scores ≥1 are key criteria used in the diagnosis of inflammation in the oral component of Sjögren's Syndrome. Higher numbers are associated with more inflammation. (Range 0-12).

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

      Focus score is the number of mononuclear cell infiltrates containing at least 50 inflammatory cells in a 4 mm² glandular section. Table data are the shift in focus score from Stage II Screening to Study Day 56. Only shift table cells with more than 0 participants were included in the Outcome Measure Data Table below.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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)

    Investigators

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

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    Responsible Party:
    National Institute of Dental and Craniofacial Research (NIDCR)
    ClinicalTrials.gov Identifier:
    NCT01316770
    Other Study ID Numbers:
    • 110094
    • 11-D-0094
    First Posted:
    Mar 16, 2011
    Last Update Posted:
    Nov 2, 2018
    Last Verified:
    Nov 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by National Institute of Dental and Craniofacial Research (NIDCR)
    Xerostomia
    Sjögren's Syndrome
    Interventional Study
    Sjogren's Syndrome
    Dry Mouth
    Additional relevant MeSH terms:
    Sjogren's Syndrome
    Xerostomia
    Syndrome
    Dexamethasone

    Study Results

    Participant Flow

    Recruitment Details 14 participants were screened in the United States. Nine of the participants were then eligible and enrolled between October, 2011 and Sep, 2013 and administered treatment.
    Pre-assignment Detail Screening occurred in two stages: Stage I (within 6 weeks before Stage II), and Stage II (within 6 weeks before randomization). Ten participants were eligible following the Stage I screening, but one subject loss their eligibility at Stage II screening because she refused the parotid biopsy.
    Arm/Group Title Dexamethasone Irrigation of Parotid Gland Placebo Irrigation of Parotid Gland
    Arm/Group Description Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28. Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
    Period Title: Overall Study
    STARTED 9 9
    COMPLETED 9 9
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title Overall Study
    Arm/Group Description Safety Population: all enrolled participants that received any parotid saline irrigation used to determine parotid filling volume during Stage I screening.
    Overall Participants 11
    Overall parotid glands 22
    Age, Customized (Count of Participants)
    18-30 years
    0
    0%
    31-40 years
    2
    18.2%
    41-50 years
    1
    9.1%
    51-60 years
    6
    54.5%
    61-65 years
    1
    9.1%
    66-70 years
    0
    0%
    Missing
    1
    9.1%
    Sex: Female, Male (Count of Participants)
    Female
    11
    100%
    Male
    0
    0%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    1
    9.1%
    Not Hispanic or Latino
    10
    90.9%
    Unknown or Not Reported
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    3
    27.3%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    2
    18.2%
    White
    5
    45.5%
    More than one race
    0
    0%
    Unknown or Not Reported
    1
    9.1%
    Region of Enrollment (Count of Participants)
    United States
    11
    100%
    Waist Circumference (cm) [Mean (Full Range) ]
    Mean (Full Range) [cm]
    98.0
    Weight (kg) [Mean (Full Range) ]
    Mean (Full Range) [kg]
    68.95
    Height (cm) [Mean (Full Range) ]
    Mean (Full Range) [cm]
    158.68
    Parotid Fill Volume (mL/min) [Median (Full Range) ]
    Parotid randomized to dexamethasone irrigation
    1.0
    Parotid randomized to placebo irrigation
    1.0
    Not randomized, right-side parotid
    0.875
    Not randomized, left-side parotid
    0.875
    Saliva Flow (mL/min) [Mean (Standard Deviation) ]
    Parotid randomized to dexamethasone irrigation
    0.21250
    (0.158850)
    Parotid randomized to placebo irrigation
    0.19096
    (0.136399)
    Focus Score (score on a scale) [Median (Full Range) ]
    Parotid randomized to dexamethasone irrigation
    2.5
    Parotid randomized to placebo irrigation
    1.5
    MRI Scan Evaluation (parotid glands) [Count of Units]
    Normal
    5
    Abnormal ncs
    4
    Abnormal cs
    0
    Not done
    0
    Normal
    5
    Abnormal ncs
    4
    Abnormal cs
    0
    Not done
    0
    Normal
    0
    Abnormal ncs
    0
    Abnormal cs
    0
    Not done
    2
    Normal
    0
    Abnormal ncs
    0
    Abnormal cs
    0
    Not done
    2
    Technetium Scan Evaluation (parotid glands) [Count of Units]
    Normal
    4
    Abnormal
    5
    Not done
    0
    Normal
    4
    Abnormal
    5
    Not done
    0
    Normal
    0
    Abnormal
    1
    Not done
    1
    Normal
    0
    Abnormal
    1
    Not done
    1
    Technetium Isotope Uptake (parotid glands) [Count of Units]
    Yes
    9
    No
    0
    Not done
    0
    Yes
    9
    No
    0
    Not done
    0
    Yes
    1
    No
    0
    Not done
    1
    Yes
    1
    No
    0
    Not done
    1
    Technetium Release with Stimulation (parotid glands) [Count of Units]
    Yes
    8
    No
    1
    Not done
    0
    Yes
    7
    No
    2
    Not done
    0
    Yes
    1
    No
    0
    Not done
    1
    Yes
    1
    No
    0
    Not done
    1

    Outcome Measures

    1. Primary Outcome
    Title Change in Parotid Salivary Flow From Baseline (Day 0) to Day 56.
    Description 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.
    Time Frame Baseline (Study Day 0) to Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Primary Efficacy Population (PEP): all enrolled participants who receive all parotid irrigations on study Days 0 and 28, have the same treatment applied to the same parotid (regardless of random assignment) at both visits, and have values for the primary endpoint (i.e., change in salivary flow from Day 0 to Day 56).
    Arm/Group Title Dexamethasone Irrigation of Parotid Gland Placebo Irrigation of Parotid Gland
    Arm/Group Description Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on Study Day 0 and Study Day 28. Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
    Measure Participants 9 9
    Mean (Standard Error) [g/min]
    -0.01120
    (0.049063)
    -0.05204
    (0.032029)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Dexamethasone Irrigation of Parotid Gland, Placebo Irrigation of Parotid Gland
    Comments The mixed models analysis included all time points but it failed to converge. Therefore, an alternative analysis was performed using a paired t-test. Because the Satterthwaite correction [that was specified in the statistical analysis plan (SAP) for the mixed model] is not available for the paired t-test, it was not performed on the paired t-test. The final analysis was based upon the raw non-transformed saliva flow rates, as these measures were appropriate for the model used.
    Type of Statistical Test Superiority
    Comments The standard deviation (SD) of the change in salivary flow was assumed to be 0.0168 for the placebo and 0.0906 for the dexamethasone parotid. The within-subject correlation between two glands was assumed to be 0.15. A total of 16 patients would be required to have 80% power to detect a one-sided 40% increase in dexamethasone-irrigated parotid glands compared with the saline irrigated parotid glands with respect to change in salivary flow from Day 0 to Day 56.
    Statistical Test of Hypothesis p-Value 0.236
    Comments No corrections were made for multiple comparisons because there was only one primary hypothesis.
    Method one-sided Paired t-test
    Comments
    2. Secondary Outcome
    Title Change in Parotid Salivary Flow From Baseline (Study Day 0) to Study Day 14.
    Description 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 hel in place by slight negative pressure. Collection time was 1 minute. The outcome measure is looking at change from baseline at Study Day 14 and not the flow at any particular time.
    Time Frame Baseline to 14 days post-baseline

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Dexamethasone Irrigation of Parotid Gland Placebo Irrigation of Parotid Gland
    Arm/Group Description Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on Study Day 0 and Study Day 28. Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
    Measure Participants 9 9
    Measure Parotid gland from one side of the mouth 9 9
    Mean (Standard Error) [g/min]
    -0.01106
    (0.075004)
    0.01875
    (0.047825)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Dexamethasone Irrigation of Parotid Gland, Placebo Irrigation of Parotid Gland
    Comments The mixed models analysis (including all time points: study days 14, 28, 42, 56) failed to converge; thus, an alternative analysis, as stated in the Statistical Analysis Plan, was performed using the paired t-test. The Satterthwaite correction (Statistical Analysis Plan) is not available for the paired t-test and was not performed on the paired t-test. The final analysis was based upon the raw non-transformed saliva flow rates since this statistical model achieved the best fit to the data.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.662
    Comments
    Method one-sided paired t-test
    Comments
    3. Secondary Outcome
    Title Change in Parotid Salivary Flow From Baseline (Day 0) to Day 28.
    Description 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 hel in place by slight negative pressure. Collection time was 1 minute. The outcome measure is looking at change from baseline at Study Day 28 and not the flow at any particular time.
    Time Frame Baseline to 28 days post-baseline

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Dexamethasone Irrigation of Parotid Gland Placebo Irrigation of Parotid Gland
    Arm/Group Description Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28. Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
    Measure Participants 9 9
    Measure Parotid gland on one side of the mouth 9 9
    Mean (Standard Error) [g/min]
    -0.09808
    (0.058960)
    -0.06678
    (0.071649)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Dexamethasone Irrigation of Parotid Gland, Placebo Irrigation of Parotid Gland
    Comments The mixed models analysis (including all time points: study days 14, 28, 42, 56) failed to converge; thus, an alternative analysis, as stated in the Statistical Analysis Plan, was performed using the paired t-test. The Satterthwaite correction (Statistical Analysis Plan) is not available for the paired t-test and was not performed on the paired t-test. The final analysis was based upon the raw non-transformed saliva flow rates since this statistical model achieved the best fit to the data.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.607
    Comments
    Method one-sided paired t-test
    Comments
    4. Secondary Outcome
    Title Change in Parotid Salivary Flow From Baseline (Day 0) to Day 42.
    Description 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 hel in place by slight negative pressure. Collection time was 1 minute. The outcome measure is looking at change from baseline at Study Day 42 and not the flow at any particular time.
    Time Frame Baseline to 42 days post-baseline

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Dexamethasone Irrigation of Parotid Gland Placebo Irrigation of Parotid Gland
    Arm/Group Description Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28. Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
    Measure Participants 9 9
    Measure Parotid galnd on one side of the mouth 9 9
    Mean (Standard Deviation) [g/min]
    0.00224
    (0.055472)
    0.01192
    (0.031049)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Dexamethasone Irrigation of Parotid Gland, Placebo Irrigation of Parotid Gland
    Comments The mixed models analysis (including all time points: study days 14, 28, 42, 56) failed to converge; thus, an alternative analysis, as stated in the Statistical Analysis Plan, was performed using the paired t-test. The Satterthwaite correction (Statistical Analysis Plan) is not available for the paired t-test and was not performed on the paired t-test. The final analysis was based upon the raw non-transformed saliva flow rates since this statistical model achieved the best fit to the data.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.586
    Comments
    Method one-sided paired t-test
    Comments
    5. Secondary Outcome
    Title Patient Dry Mouth Questionnaire. Question: Do You Have More Difficulty Chewing Your Food Since Starting the Study?
    Description The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.
    Time Frame Baseline (Study Day 0) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Yes
    3
    27.3%
    No
    6
    54.5%
    Yes
    1
    9.1%
    No
    8
    72.7%
    Yes
    2
    18.2%
    No
    7
    63.6%
    Yes
    1
    9.1%
    No
    8
    72.7%
    Yes
    2
    18.2%
    No
    7
    63.6%
    6. Secondary Outcome
    Title Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why?
    Description The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.
    Time Frame Baseline (Study Day 0) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Pain
    0
    0%
    Dryness
    3
    27.3%
    Weakness
    0
    0%
    Too few Teeth
    0
    0%
    Other
    0
    0%
    Pain
    0
    0%
    Dryness
    1
    9.1%
    Weakness
    0
    0%
    Too few Teeth
    0
    0%
    Other
    0
    0%
    Pain
    0
    0%
    Dryness
    2
    18.2%
    Weakness
    0
    0%
    Too few Teeth
    0
    0%
    Other
    0
    0%
    Pain
    0
    0%
    Dryness
    1
    9.1%
    Weakness
    0
    0%
    Too few Teeth
    0
    0%
    Other
    0
    0%
    Pain
    0
    0%
    Dryness
    2
    18.2%
    Weakness
    0
    0%
    Too few Teeth
    0
    0%
    Other
    0
    0%
    7. Secondary Outcome
    Title Patient Dry Mouth Questionnaire. Question: Have You Experienced Any Changes in Your Sense of Smell Since Starting the Study?
    Description The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.
    Time Frame Baseline (Study Day 0) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Yes
    0
    0%
    No
    9
    81.8%
    Yes
    0
    0%
    No
    9
    81.8%
    Yes
    0
    0%
    No
    9
    81.8%
    Yes
    0
    0%
    No
    9
    81.8%
    Yes
    0
    0%
    No
    9
    81.8%
    8. Secondary Outcome
    Title Patient Dry Mouth Questionnaire: Have You Experienced Any Changes in Your Sense of Taste Since Starting the Study?
    Description The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.
    Time Frame Baseline (Study Day 0) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Yes
    1
    9.1%
    No
    8
    72.7%
    Yes
    2
    18.2%
    No
    7
    63.6%
    Yes
    1
    9.1%
    No
    8
    72.7%
    Yes
    0
    0%
    No
    9
    81.8%
    Yes
    0
    0%
    No
    9
    81.8%
    9. Secondary Outcome
    Title Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify:
    Description The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible.
    Time Frame Baseline (Study Day 0) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Foods taste different than they used to
    0
    0%
    Foods taste less intense (for example, less sweet)
    0
    0%
    Foods taste more intense (for example, more sweet)
    1
    9.1%
    I have persistent bad taste in my mouth
    0
    0%
    Foods taste different than they used to
    0
    0%
    Foods taste less intense (for example, less sweet)
    1
    9.1%
    Foods taste more intense (for example, more sweet)
    1
    9.1%
    I have persistent bad taste in my mouth
    0
    0%
    Foods taste different than they used to
    1
    9.1%
    Foods taste less intense (for example, less sweet)
    0
    0%
    Foods taste more intense (for example, more sweet)
    0
    0%
    I have persistent bad taste in my mouth
    0
    0%
    Foods taste different than they used to
    0
    0%
    Foods taste less intense (for example, less sweet)
    0
    0%
    Foods taste more intense (for example, more sweet)
    0
    0%
    I have persistent bad taste in my mouth
    0
    0%
    Foods taste different than they used to
    0
    0%
    Foods taste less intense (for example, less sweet)
    0
    0%
    Foods taste more intense (for example, more sweet)
    0
    0%
    I have persistent bad taste in my mouth
    0
    0%
    10. Secondary Outcome
    Title Patient Dry Mouth Questionnaire: Do You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study?
    Description The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.
    Time Frame Baseline (Study Day 0) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title All Study Participants
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Yes
    2
    18.2%
    No
    7
    63.6%
    Yes
    2
    18.2%
    No
    7
    63.6%
    Yes
    1
    9.1%
    No
    8
    72.7%
    Yes
    1
    9.1%
    No
    8
    72.7%
    Yes
    1
    9.1%
    No
    8
    72.7%
    11. Secondary Outcome
    Title 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:
    Description The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible.
    Time Frame Baseline (Study Day 0) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Mouth or tongue burns
    1
    9.1%
    I have tooth pain
    0
    0%
    I have gum pain
    0
    0%
    I have pain in my jaws or TMJ
    1
    9.1%
    Mouth or tongue burns
    1
    9.1%
    I have tooth pain
    0
    0%
    I have gum pain
    0
    0%
    I have pain in my jaws or TMJ
    1
    9.1%
    Mouth or tongue burns
    0
    0%
    I have tooth pain
    0
    0%
    I have gum pain
    0
    0%
    I have pain in my jaws or TMJ
    1
    9.1%
    Mouth or tongue burns
    1
    9.1%
    I have tooth pain
    0
    0%
    I have gum pain
    0
    0%
    I have pain in my jaws or TMJ
    0
    0%
    Mouth or tongue burns
    0
    0%
    I have tooth pain
    0
    0%
    I have gum pain
    0
    0%
    I have pain in my jaws or TMJ
    1
    9.1%
    12. Secondary Outcome
    Title Patient Dry Mouth Questionnaire: Do You Use Anything to Keep Your Mouth Moist?
    Description The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.
    Time Frame Baseline (Study Day 0) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Yes
    8
    72.7%
    No
    1
    9.1%
    Yes
    9
    81.8%
    No
    0
    0%
    Yes
    9
    81.8%
    No
    0
    0%
    Yes
    9
    81.8%
    No
    0
    0%
    Yes
    8
    72.7%
    No
    1
    9.1%
    13. Secondary Outcome
    Title Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify:
    Description The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible.
    Time Frame Baseline (Study Day 0) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Baseline: Sip water
    8
    72.7%
    Baseline: Sip liquids other than water
    6
    54.5%
    Baseline: use commercial products
    4
    36.4%
    Baseline: Chew sugared gum or mints
    1
    9.1%
    Baseline: Chew sugarless gum or mints
    2
    18.2%
    Study Day 14: Sip water
    8
    72.7%
    Study Day 14: Sip liquids other than water
    6
    54.5%
    Study Day 14: use commercial products
    3
    27.3%
    Study Day 14: Chew sugared gum or mints
    1
    9.1%
    Study Day 14: Chew sugarless gum or mints
    4
    36.4%
    Study Day 28: Sip water
    8
    72.7%
    Study Day 28: Sip liquids other than water
    7
    63.6%
    Study Day 28: use commercial products
    4
    36.4%
    Study Day 28: Chew sugared gum or mints
    2
    18.2%
    Study Day 28: Chew sugarless gum or mints
    3
    27.3%
    Study Day 42: Sip water
    7
    63.6%
    Study Day 42: Sip liquids other than water
    5
    45.5%
    Study Day 42: use commercial products
    3
    27.3%
    Study Day 42: Chew sugared gum or mints
    2
    18.2%
    Study Day 42: Chew sugarless gum or mints
    3
    27.3%
    Study Day 56: Sip water
    8
    72.7%
    Study Day 56: Sip liquids other than water
    3
    27.3%
    Study Day 56: use commercial products
    3
    27.3%
    Study Day 56: Chew sugared gum or mints
    1
    9.1%
    Study Day 56: Chew sugarless gum or mints
    2
    18.2%
    14. Secondary Outcome
    Title Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study?
    Description The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes; No; Not sure.
    Time Frame Baseline (Study Day 0) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Yes
    1
    9.1%
    No
    6
    54.5%
    Not Sure
    2
    18.2%
    Yes
    1
    9.1%
    No
    7
    63.6%
    Not Sure
    1
    9.1%
    Yes
    2
    18.2%
    No
    7
    63.6%
    Not Sure
    0
    0%
    Yes
    1
    9.1%
    No
    8
    72.7%
    Not Sure
    0
    0%
    Yes
    1
    9.1%
    No
    7
    63.6%
    Not Sure
    1
    9.1%
    15. Secondary Outcome
    Title Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study?
    Description The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes; No; Not sure.
    Time Frame Baseline (Study Day 0) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Yes
    3
    27.3%
    No
    6
    54.5%
    Not Sure
    0
    0%
    Yes
    5
    45.5%
    No
    3
    27.3%
    Not Sure
    1
    9.1%
    Yes
    3
    27.3%
    No
    5
    45.5%
    Not Sure
    1
    9.1%
    Yes
    2
    18.2%
    No
    5
    45.5%
    Not Sure
    2
    18.2%
    Yes
    2
    18.2%
    No
    6
    54.5%
    Not Sure
    1
    9.1%
    16. Secondary Outcome
    Title Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be:
    Description The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: To little; to much; Do not notice it.
    Time Frame Baseline (Study Day 0) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Too little
    4
    36.4%
    Too much
    0
    0%
    Do not notice it
    5
    45.5%
    Too little
    6
    54.5%
    Too much
    0
    0%
    Do not notice it
    3
    27.3%
    Too little
    5
    45.5%
    Too much
    0
    0%
    Do not notice it
    4
    36.4%
    Too little
    5
    45.5%
    Too much
    0
    0%
    Do not notice it
    4
    36.4%
    Too little
    4
    36.4%
    Too much
    0
    0%
    Do not notice it
    5
    45.5%
    17. Secondary Outcome
    Title Patient Dry Mouth Questionnaire: Do You Have More Difficulty Swallowing Dry Foods Without Additional Liquids Since Starting the Study?
    Description The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.
    Time Frame Baseline (Study Day 0) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Yes
    1
    9.1%
    No
    8
    72.7%
    Yes
    1
    9.1%
    No
    8
    72.7%
    Yes
    3
    27.3%
    No
    6
    54.5%
    Yes
    3
    27.3%
    No
    6
    54.5%
    Yes
    1
    9.1%
    No
    8
    72.7%
    18. Secondary Outcome
    Title Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food?
    Description Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56
    Time Frame Baseline (Study Day 0) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Screening II: Yes; Study Day: Yes
    1
    9.1%
    Screening II: Yes; Study Day: No
    2
    18.2%
    Screening II: No; Study Day: Yes
    0
    0%
    Screening II: No; Study Day: No
    6
    54.5%
    Screening II: Yes; Study Day: Yes
    1
    9.1%
    Screening II: Yes; Study Day: No
    2
    18.2%
    Screening II: No; Study Day: Yes
    1
    9.1%
    Screening II: No; Study Day: No
    5
    45.5%
    Screening II: Yes; Study Day: Yes
    1
    9.1%
    Screening II: Yes; Study Day: No
    2
    18.2%
    Screening II: No; Study Day: Yes
    0
    0%
    Screening II: No; Study Day: No
    6
    54.5%
    Screening II: Yes; Study Day: Yes
    2
    18.2%
    Screening II: Yes; Study Day: No
    1
    9.1%
    Screening II: No; Study Day: Yes
    0
    0%
    Screening II: No; Study Day: No
    6
    54.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Dexamethasone Irrigation of Parotid Gland
    Comments McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 14 are equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 14. Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 14 is not equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 14.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.500
    Comments
    Method McNemar
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dexamethasone Irrigation of Parotid Gland
    Comments McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 28 is equal to the probability of subjects shifting their answer from "no" at Screening to "yes" at Study Day 28. Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 28 is not equal to the probability of subjects shifting their answer from "no" at Screening to "yes" at Study Day 28.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.000
    Comments
    Method McNemar
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Dexamethasone Irrigation of Parotid Gland
    Comments McNemar's test on the study Day 42 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 42 are equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 42. Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 42 is not equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 42.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.500
    Comments
    Method McNemar
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Dexamethasone Irrigation of Parotid Gland
    Comments McNemar's test on the study Day 56 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 56 are equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 56. Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 56 is not equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 56.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.000
    Comments
    Method McNemar
    Comments
    19. Secondary Outcome
    Title Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell?
    Description Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56. The shift table data were not sufficiently distributed to permit analysis with McNemar's test on any of the study days.
    Time Frame Baseline (Study Day 0) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Screening II: Yes; Study Day: Yes
    0
    0%
    Screening II: Yes; Study Day: No
    0
    0%
    Screening II: No; Study Day: Yes
    0
    0%
    Screening II: No; Study Day: No
    9
    81.8%
    Screening II: Yes; Study Day: Yes
    0
    0%
    Screening II: Yes; Study Day: No
    0
    0%
    Screening II: No; Study Day: Yes
    0
    0%
    Screening II: No; Study Day: No
    9
    81.8%
    Screening II: Yes; Study Day: Yes
    0
    0%
    Screening II: Yes; Study Day: No
    0
    0%
    Screening II: No; Study Day: Yes
    0
    0%
    Screening II: No; Study Day: No
    9
    81.8%
    Screening II: Yes; Study Day: Yes
    0
    0%
    Screening II: Yes; Study Day: No
    0
    0%
    Screening II: No; Study Day: Yes
    0
    0%
    Screening II: No; Study Day: No
    9
    81.8%
    20. Secondary Outcome
    Title Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste?
    Description Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56. The shift table data were not sufficiently distributed to permit analysis with McNemar's test on Study Days 42 and 56.
    Time Frame Baseline (Study Day 0) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Screening II: Yes; Study Day: Yes
    1
    9.1%
    Screening II: Yes; Study Day: No
    0
    0%
    Screening II: No; Study Day: Yes
    1
    9.1%
    Screening II: No; Study Day: No
    7
    63.6%
    Screening II: Yes; Study Day: Yes
    0
    0%
    Screening II: Yes; Study Day: No
    1
    9.1%
    Screening II: No; Study Day: Yes
    1
    9.1%
    Screening II: No; Study Day: No
    7
    63.6%
    Screening II: Yes; Study Day: Yes
    0
    0%
    Screening II: Yes; Study Day: No
    1
    9.1%
    Screening II: No; Study Day: Yes
    0
    0%
    Screening II: No; Study Day: No
    8
    72.7%
    Screening II: Yes; Study Day: Yes
    0
    0%
    Screening II: Yes; Study Day: No
    1
    9.1%
    Screening II: No; Study Day: Yes
    0
    0%
    Screening II: No; Study Day: No
    8
    72.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Dexamethasone Irrigation of Parotid Gland
    Comments McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 14 are equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 14. Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 14 is not equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 14.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.000
    Comments
    Method McNemar
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dexamethasone Irrigation of Parotid Gland
    Comments McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 28 is equal to the probability of subjects shifting their answer from "no" at Screening to "yes" at Study Day 28. Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 28 is not equal to the probability of subjects shifting their answer from "no" at Screening to "yes" at Study Day 28.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.000
    Comments
    Method McNemar
    Comments
    21. Secondary Outcome
    Title Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck?
    Description Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56
    Time Frame Baseline (Study Day 0) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Screening II: Yes; Study Day: Yes
    1
    9.1%
    Screening II: Yes; Study Day: No
    1
    9.1%
    Screening II: No; Study Day: Yes
    1
    9.1%
    Screening II: No; Study Day: No
    6
    54.5%
    Screening II: Yes; Study Day: Yes
    1
    9.1%
    Screening II: Yes; Study Day: No
    1
    9.1%
    Screening II: No; Study Day: Yes
    0
    0%
    Screening II: No; Study Day: No
    7
    63.6%
    Screening II: Yes; Study Day: Yes
    1
    9.1%
    Screening II: Yes; Study Day: No
    1
    9.1%
    Screening II: No; Study Day: Yes
    0
    0%
    Screening II: No; Study Day: No
    7
    63.6%
    Screening II: Yes; Study Day: Yes
    1
    9.1%
    Screening II: Yes; Study Day: No
    1
    9.1%
    Screening II: No; Study Day: Yes
    0
    0%
    Screening II: No; Study Day: No
    7
    63.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Dexamethasone Irrigation of Parotid Gland
    Comments McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 14 are equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 14. Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 14 is not equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 14.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.000
    Comments
    Method McNemar
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dexamethasone Irrigation of Parotid Gland
    Comments McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 28 is equal to the probability of subjects shifting their answer from "no" at Screening to "yes" at Study Day 28. Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 28 is not equal to the probability of subjects shifting their answer from "no" at Screening to "yes" at Study Day 28.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.000
    Comments
    Method McNemar
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Dexamethasone Irrigation of Parotid Gland
    Comments McNemar's test on the study Day 42 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 42 are equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 42. Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 42 is not equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 42.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.000
    Comments
    Method McNemar
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Dexamethasone Irrigation of Parotid Gland
    Comments McNemar's test on the study Day 56 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 56 are equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 56. Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 56 is not equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 56.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.000
    Comments
    Method McNemar
    Comments
    22. Secondary Outcome
    Title Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist?
    Description Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56. The shift table data were not sufficiently distributed to permit analysis with McNemar's test on any of the study days.
    Time Frame Baseline (Study Day 0) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Screening II: Yes; Study Day: Yes
    8
    72.7%
    Screening II: Yes; Study Day: No
    0
    0%
    Screening II: No; Study Day: Yes
    1
    9.1%
    Screening II: No; Study Day: No
    0
    0%
    Screening II: Yes; Study Day: Yes
    8
    72.7%
    Screening II: Yes; Study Day: No
    0
    0%
    Screening II: No; Study Day: Yes
    1
    9.1%
    Screening II: No; Study Day: No
    0
    0%
    Screening II: Yes; Study Day: Yes
    8
    72.7%
    Screening II: Yes; Study Day: No
    0
    0%
    Screening II: No; Study Day: Yes
    1
    9.1%
    Screening II: No; Study Day: No
    0
    0%
    Screening II: Yes; Study Day: Yes
    8
    72.7%
    Screening II: Yes; Study Day: No
    0
    0%
    Screening II: No; Study Day: Yes
    0
    0%
    Screening II: No; Study Day: No
    1
    9.1%
    23. Secondary Outcome
    Title Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat?
    Description Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56. The shift table data were not sufficiently distributed to permit analysis with McNemar's test on any of the study days.
    Time Frame Baseline (Study Day 0) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0. The shift tables were limited to binary outcomes; participants that answered "not sure" were excluded from the shift tables.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Screening II: Yes; Study Day: Yes
    1
    9.1%
    Screening II: Yes; Study Day: No
    0
    0%
    Screening II: No; Study Day: Yes
    0
    0%
    Screening II: No; Study Day: No
    5
    45.5%
    Screening II: Yes; Study Day: Yes
    1
    9.1%
    Screening II: Yes; Study Day: No
    0
    0%
    Screening II: No; Study Day: Yes
    0
    0%
    Screening II: No; Study Day: No
    6
    54.5%
    Screening II: Yes; Study Day: Yes
    1
    9.1%
    Screening II: Yes; Study Day: No
    0
    0%
    Screening II: No; Study Day: Yes
    0
    0%
    Screening II: No; Study Day: No
    6
    54.5%
    Screening II: Yes; Study Day: Yes
    1
    9.1%
    Screening II: Yes; Study Day: No
    0
    0%
    Screening II: No; Study Day: Yes
    0
    0%
    Screening II: No; Study Day: No
    5
    45.5%
    24. Secondary Outcome
    Title Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day?
    Description Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56
    Time Frame Baseline (Study Day 0) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0. The shift tables were limited to binary outcomes; participants that answered "not sure" were excluded from the shift tables.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Screening II: Yes; Study Day: Yes
    2
    18.2%
    Screening II: Yes; Study Day: No
    0
    0%
    Screening II: No; Study Day: Yes
    3
    27.3%
    Screening II: No; Study Day: No
    3
    27.3%
    Screening II: Yes; Study Day: Yes
    1
    9.1%
    Screening II: Yes; Study Day: No
    1
    9.1%
    Screening II: No; Study Day: Yes
    2
    18.2%
    Screening II: No; Study Day: No
    4
    36.4%
    Screening II: Yes; Study Day: Yes
    1
    9.1%
    Screening II: Yes; Study Day: No
    0
    0%
    Screening II: No; Study Day: Yes
    1
    9.1%
    Screening II: No; Study Day: No
    5
    45.5%
    Screening II: Yes; Study Day: Yes
    1
    9.1%
    Screening II: Yes; Study Day: No
    1
    9.1%
    Screening II: No; Study Day: Yes
    1
    9.1%
    Screening II: No; Study Day: No
    5
    45.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Dexamethasone Irrigation of Parotid Gland
    Comments McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 14 are equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 14. Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 14 is not equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 14.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.250
    Comments
    Method McNemar
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dexamethasone Irrigation of Parotid Gland
    Comments McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 28 is equal to the probability of subjects shifting their answer from "no" at Screening to "yes" at Study Day 28. Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 28 is not equal to the probability of subjects shifting their answer from "no" at Screening to "yes" at Study Day 28.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.000
    Comments
    Method McNemar
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Dexamethasone Irrigation of Parotid Gland
    Comments McNemar's test on the study Day 42 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 42 are equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 42. Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 42 is not equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 42.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.000
    Comments
    Method McNemar
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Dexamethasone Irrigation of Parotid Gland
    Comments McNemar's test on the study Day 56 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 56 are equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 56. Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 56 is not equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 56.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.000
    Comments
    Method McNemar
    Comments
    25. Secondary Outcome
    Title Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids?
    Description Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56
    Time Frame Baseline (Study Day 0) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0. The shift tables were limited to binary outcomes; participants that answered "not sure" were excluded from the shift tables.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Screening II: Yes; Study Day: Yes
    0
    0%
    Screening II: Yes; Study Day: No
    1
    9.1%
    Screening II: No; Study Day: Yes
    1
    9.1%
    Screening II: No; Study Day: No
    7
    63.6%
    Screening II: Yes; Study Day: Yes
    0
    0%
    Screening II: Yes; Study Day: No
    1
    9.1%
    Screening II: No; Study Day: Yes
    3
    27.3%
    Screening II: No; Study Day: No
    5
    45.5%
    Screening II: Yes; Study Day: Yes
    1
    9.1%
    Screening II: Yes; Study Day: No
    0
    0%
    Screening II: No; Study Day: Yes
    2
    18.2%
    Screening II: No; Study Day: No
    6
    54.5%
    Screening II: Yes; Study Day: Yes
    0
    0%
    Screening II: Yes; Study Day: No
    1
    9.1%
    Screening II: No; Study Day: Yes
    1
    9.1%
    Screening II: No; Study Day: No
    7
    63.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Dexamethasone Irrigation of Parotid Gland
    Comments McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 14 are equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 14. Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 14 is not equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 14.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.000
    Comments
    Method McNemar
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dexamethasone Irrigation of Parotid Gland
    Comments McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 28 is equal to the probability of subjects shifting their answer from "no" at Screening to "yes" at Study Day 28. Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 28 is not equal to the probability of subjects shifting their answer from "no" at Screening to "yes" at Study Day 28.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.625
    Comments
    Method McNemar
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Dexamethasone Irrigation of Parotid Gland
    Comments McNemar's test on the study Day 42 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 42 are equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 42. Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 42 is not equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 42.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5000
    Comments
    Method McNemar
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Dexamethasone Irrigation of Parotid Gland
    Comments McNemar's test on the study Day 56 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 56 are equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 56. Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 56 is not equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 56.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.000
    Comments
    Method McNemar
    Comments
    26. Secondary Outcome
    Title Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Ordinal Numeric Scale)
    Description Ordinal Scale 0:least to 10:greatest level of disease activity
    Time Frame Baseline (Study Day 0) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0. The shift tables were limited to binary outcomes; participants that answered "not sure" were excluded from the shift tables.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Baseline
    5
    Study Day 14
    5
    Study Day 28
    5
    Study Day 42
    5
    Study Day 56
    5
    27. Secondary Outcome
    Title Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale)
    Description Nominal scale values: Inactive; Low; Moderate; High
    Time Frame Baseline (Study Day 0) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0. The shift tables were limited to binary outcomes; participants that answered "not sure" were excluded from the shift tables.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Inactive
    0
    0%
    Low
    2
    18.2%
    Moderate
    7
    63.6%
    High
    0
    0%
    Inactive
    0
    0%
    Low
    2
    18.2%
    Moderate
    7
    63.6%
    High
    0
    0%
    Inactive
    0
    0%
    Low
    2
    18.2%
    Moderate
    7
    63.6%
    High
    0
    0%
    Inactive
    0
    0%
    Low
    3
    27.3%
    Moderate
    6
    54.5%
    High
    0
    0%
    Inactive
    0
    0%
    Low
    4
    36.4%
    Moderate
    5
    45.5%
    High
    0
    0%
    28. Secondary Outcome
    Title Sjögren's Disease Activity Index: Do You Consider Your Patient in a Satisfactory State of 'Minimal Disease Activity'?
    Description Response: Yes or No
    Time Frame Baseline (Study Day 0) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0. The shift tables were limited to binary outcomes; participants that answered "not sure" were excluded from the shift tables.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Yes
    0
    0%
    No
    9
    81.8%
    Yes
    0
    0%
    No
    9
    81.8%
    Yes
    0
    0%
    No
    9
    81.8%
    Yes
    0
    0%
    No
    9
    81.8%
    Yes
    0
    0%
    No
    9
    81.8%
    29. Secondary Outcome
    Title 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
    Description Ordinal Scale 0: least to 10: greatest level of disease activity.
    Time Frame Baseline (Study Day 0) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0. The shift tables were limited to binary outcomes; participants that answered "not sure" were excluded from the shift tables.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Baseline
    5
    Study Day 14
    5
    Study Day 28
    5
    Study Day 42
    5
    Study Day 56
    5
    30. Secondary Outcome
    Title Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now:
    Description Nominal Scale: Much better; Better; The same; Worse; Much worse
    Time Frame Baseline (Study Day 0) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0. The shift tables were limited to binary outcomes; participants that answered "not sure" were excluded from the shift tables.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Much better
    0
    0%
    Better
    0
    0%
    The same
    7
    63.6%
    Worse
    2
    18.2%
    Much worse
    0
    0%
    Much better
    0
    0%
    Better
    0
    0%
    The same
    7
    63.6%
    Worse
    2
    18.2%
    Much worse
    0
    0%
    Much better
    0
    0%
    Better
    0
    0%
    The same
    7
    63.6%
    Worse
    2
    18.2%
    Much worse
    0
    0%
    Much better
    0
    0%
    Better
    0
    0%
    The same
    9
    81.8%
    Worse
    0
    0%
    Much worse
    0
    0%
    Much better
    0
    0%
    Better
    1
    9.1%
    The same
    8
    72.7%
    Worse
    0
    0%
    Much worse
    0
    0%
    31. Secondary Outcome
    Title 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):
    Description Response: Yes; No
    Time Frame Baseline (Study Day 0) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Yes
    1
    9.1%
    No
    8
    72.7%
    Yes
    2
    18.2%
    No
    7
    63.6%
    Yes
    2
    18.2%
    No
    7
    63.6%
    Yes
    0
    0%
    No
    9
    81.8%
    Yes
    0
    0%
    No
    9
    81.8%
    32. Secondary Outcome
    Title 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.
    Description Possible Response: Yes or No
    Time Frame Baseline (Study Day 0) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Yes
    0
    0%
    No
    9
    81.8%
    Yes
    0
    0%
    No
    9
    81.8%
    Yes
    0
    0%
    No
    9
    81.8%
    Yes
    0
    0%
    No
    9
    81.8%
    33. Secondary Outcome
    Title Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 14 , Ordinal Scores
    Description Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.
    Time Frame Baseline (Study Day 0) through Study Day 14

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Baseline SDAI=5; Study Day 14 SDAI=5
    4
    36.4%
    Baseline SDAI=5; Study Day 14 SDAI=6
    1
    9.1%
    Baseline SDAI=6; Study Day 14 SDAI=5
    1
    9.1%
    Baseline SDAI=6; Study Day 14 SDAI=6
    1
    9.1%
    Baseline SDAI=6; Study Day 14 SDAI=7
    1
    9.1%
    Baseline SDAI=7; Study Day 14 SDAI=7
    1
    9.1%
    34. Secondary Outcome
    Title Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 28 , Ordinal Scores
    Description Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.
    Time Frame Baseline (Study Day 0) through Study Day 28

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Baseline SDAI=5; Study Day 28 SDAI=5
    4
    36.4%
    Baseline SDAI=5; Study Day 28 SDAI=6
    1
    9.1%
    Baseline SDAI=6; Study Day 28 SDAI=5
    2
    18.2%
    Baseline SDAI=6; Study Day 28 SDAI=7
    1
    9.1%
    Baseline SDAI=7; Study Day 28 SDAI=7
    1
    9.1%
    35. Secondary Outcome
    Title Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 42 , Ordinal Scores
    Description Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.
    Time Frame Baseline (Study Day 0) through Study Day 42

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Baseline SDAI=5; Study Day 42 SDAI=5
    4
    36.4%
    Baseline SDAI=5; Study Day 42 SDAI=6
    1
    9.1%
    Baseline SDAI=6; Study Day 42 SDAI=5
    1
    9.1%
    Baseline SDAI=6; Study Day 42 SDAI=6
    2
    18.2%
    Baseline SDAI=7; Study Day 42 SDAI=7
    1
    9.1%
    36. Secondary Outcome
    Title Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 56 , Ordinal Scores
    Description Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.
    Time Frame Baseline (Study Day 0) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Baseline SDAI=5; Study Day 56 SDAI=4
    1
    9.1%
    Baseline SDAI=5; Study Day 56 SDAI=5
    3
    27.3%
    Baseline SDAI=5; Study Day 56 SDAI=6
    1
    9.1%
    Baseline SDAI=6; Study Day 56 SDAI=5
    2
    18.2%
    Baseline SDAI=6; Study Day 56 SDAI=6
    1
    9.1%
    Baseline SDAI=7; Study Day 56 SDAI=7
    1
    9.1%
    37. Secondary Outcome
    Title 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
    Description Possible response on nominal scale: Inactive; Low; Moderate; High SDAI.
    Time Frame Baseline (Study Day 0) to Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Baseline Inactive to Study Day Inactive
    0
    0%
    Baseline Inactive to Study Day Low
    0
    0%
    Baseline Inactive to Study Day Moderate
    0
    0%
    Baseline Inactive to Study Day High
    0
    0%
    Baseline Low to Study Day Inactive
    0
    0%
    Baseline Low to Study Day Low
    2
    18.2%
    Baseline Low to Study Day Moderate
    0
    0%
    Baseline Low to Study Day High
    0
    0%
    Baseline Moderate to Study Day Inactive
    0
    0%
    Baseline Moderate to Study Day Low
    0
    0%
    Baseline Moderate to Study Day Moderate
    7
    63.6%
    Baseline Moderate to Study Day High
    0
    0%
    Baseline High to Study Day Inactive
    0
    0%
    Baseline High to Study Day Low
    0
    0%
    Baseline High to Study Day Moderate
    0
    0%
    Baseline High to Study Day High
    0
    0%
    Baseline Inactive to Study Day Inactive
    0
    0%
    Baseline Inactive to Study Day Low
    0
    0%
    Baseline Inactive to Study Day Moderate
    0
    0%
    Baseline Inactive to Study Day High
    0
    0%
    Baseline Low to Study Day Inactive
    0
    0%
    Baseline Low to Study Day Low
    2
    18.2%
    Baseline Low to Study Day Moderate
    0
    0%
    Baseline Low to Study Day High
    0
    0%
    Baseline Moderate to Study Day Inactive
    0
    0%
    Baseline Moderate to Study Day Low
    0
    0%
    Baseline Moderate to Study Day Moderate
    7
    63.6%
    Baseline Moderate to Study Day High
    0
    0%
    Baseline High to Study Day Inactive
    0
    0%
    Baseline High to Study Day Low
    0
    0%
    Baseline High to Study Day Moderate
    0
    0%
    Baseline High to Study Day High
    0
    0%
    Baseline Inactive to Study Day Inactive
    0
    0%
    Baseline Inactive to Study Day Low
    0
    0%
    Baseline Inactive to Study Day Moderate
    0
    0%
    Baseline Inactive to Study Day High
    0
    0%
    Baseline Low to Study Day Inactive
    0
    0%
    Baseline Low to Study Day Low
    2
    18.2%
    Baseline Low to Study Day Moderate
    0
    0%
    Baseline Low to Study Day High
    0
    0%
    Baseline Moderate to Study Day Inactive
    0
    0%
    Baseline Moderate to Study Day Low
    1
    9.1%
    Baseline Moderate to Study Day Moderate
    6
    54.5%
    Baseline Moderate to Study Day High
    0
    0%
    Baseline High to Study Day Inactive
    0
    0%
    Baseline High to Study Day Low
    0
    0%
    Baseline High to Study Day Moderate
    0
    0%
    Baseline High to Study Day High
    0
    0%
    Baseline Inactive to Study Day Inactive
    0
    0%
    Baseline Inactive to Study Day Low
    0
    0%
    Baseline Inactive to Study Day Moderate
    0
    0%
    Baseline Inactive to Study Day High
    0
    0%
    Baseline Low to Study Day Inactive
    0
    0%
    Baseline Low to Study Day Low
    2
    18.2%
    Baseline Low to Study Day Moderate
    0
    0%
    Baseline Low to Study Day High
    0
    0%
    Baseline Moderate to Study Day Inactive
    0
    0%
    Baseline Moderate to Study Day Low
    2
    18.2%
    Baseline Moderate to Study Day Moderate
    5
    45.5%
    Baseline Moderate to Study Day High
    0
    0%
    Baseline High to Study Day Inactive
    0
    0%
    Baseline High to Study Day Low
    0
    0%
    Baseline High to Study Day Moderate
    0
    0%
    Baseline High to Study Day High
    0
    0%
    38. Secondary Outcome
    Title 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
    Description Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.
    Time Frame Baseline (Study Day 0) to Study Day 14

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Baseline SDAI=4; Study Day 14 SDAI=4
    1
    9.1%
    Baseline SDAI=5; Study Day 14 SDAI=5
    4
    36.4%
    Baseline SDAI=6; Study Day 14 SDAI=5
    2
    18.2%
    Baseline SDAI=6; Study Day 14 SDAI=7
    1
    9.1%
    Baseline SDAI=7; Study Day 14 SDAI=7
    1
    9.1%
    39. Secondary Outcome
    Title 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
    Description Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.
    Time Frame Baseline (Study Day 0) to Study Day 28

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Baseline SDAI=4; Study Day 28 SDAI=4
    1
    9.1%
    Baseline SDAI=5; Study Day 28 SDAI=5
    4
    36.4%
    Baseline SDAI=6; Study Day 28 SDAI=5
    2
    18.2%
    Baseline SDAI=6; Study Day 28 SDAI=7
    1
    9.1%
    Baseline SDAI=7; Study Day 28 SDAI=7
    1
    9.1%
    40. Secondary Outcome
    Title 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
    Description Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.
    Time Frame Baseline (Study Day 0) to Study Day 42

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Baseline SDAI=4; Study Day 42 SDAI=5
    1
    9.1%
    Baseline SDAI=5; Study Day 42 SDAI=5
    4
    36.4%
    Baseline SDAI=6; Study Day 42 SDAI=5
    3
    27.3%
    Baseline SDAI=7; Study Day 42 SDAI=7
    1
    9.1%
    41. Secondary Outcome
    Title 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
    Description Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.
    Time Frame Baseline (Study Day 0) to Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Overall Study
    Arm/Group Description Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
    Measure Participants 9
    Baseline SDAI=4; Study Day 56 SDAI=5
    1
    9.1%
    Baseline SDAI=5; Study Day 56 SDAI=5
    4
    36.4%
    Baseline SDAI=6; Study Day 56 SDAI=5
    3
    27.3%
    Baseline SDAI=7; Study Day 56 SDAI=7
    1
    9.1%
    42. Secondary Outcome
    Title Summary Statistics of MRI Scans
    Description Medical evaluations of MRI Scans. Possible evaluations include: i) Normal; ii) Abnormal, not clinically significant; iii) Abnormal, clinically significant.
    Time Frame Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Dexamethasone Irrigation of Parotid Gland Placebo Irrigation of Parotid Gland
    Arm/Group Description Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28. Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
    Measure Participants 9 9
    MRI Normal
    5
    45.5%
    5
    22.7%
    MRI Abnormal, not clinically signficant
    4
    36.4%
    4
    18.2%
    MRI Abnormal, clinically signficant
    0
    0%
    0
    0%
    MRI Normal
    5
    45.5%
    6
    27.3%
    MRI Abnormal, not clinically signficant
    3
    27.3%
    3
    13.6%
    MRI Abnormal, clinically signficant
    1
    9.1%
    0
    0%
    43. Secondary Outcome
    Title Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit
    Description Change in the evaluations of the parotid MRI scans at Study Day 56 from Stage II Screening Visit. Possible MRI evaluations at both Baseline and Study Day 56 include: i)Normal; ii) Abnormal, not clinically significant (Abnormal ncs); and iii) Abnormal, clinically significant (Abnormal cs).
    Time Frame Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Dexamethasone Irrigation of Parotid Gland Placebo Irrigation of Parotid Gland
    Arm/Group Description Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28. Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
    Measure Participants 9 9
    Screening Normal; Study Day 56 Normal
    4
    36.4%
    5
    22.7%
    Screening Normal; Study Day 56 Abnormal ncs
    0
    0%
    0
    0%
    Screening Normal; Study Day 56 Abnormal cs
    1
    9.1%
    0
    0%
    Screening Abnormal ncs; Study Day 56 Normal
    1
    9.1%
    1
    4.5%
    Screening Abnormal ncs; Study Day 56 Abnormal ncs
    3
    27.3%
    3
    13.6%
    Screening Abnormal ncs; Study Day 56 Abnormal cs
    0
    0%
    0
    0%
    Screening Abnormal cs; Study Day 56 Normal
    0
    0%
    0
    0%
    Screening Abnormal cs; Study Day 56 Abnormal ncs
    0
    0%
    0
    0%
    Screening Abnormal cs; Study Day 56 Abnormal cs
    0
    0%
    0
    0%
    44. Secondary Outcome
    Title Summary Statistics of Technetium Scans
    Description Medical evaluations of Technetium Scans. Possible evaluations include: i) Normal; and ii) Abnormal.
    Time Frame Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Dexamethasone Irrigation of Parotid Gland Placebo Irrigation of Parotid Gland
    Arm/Group Description Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28. Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
    Measure Participants 9 9
    Normal
    4
    36.4%
    4
    18.2%
    Abnormal
    5
    45.5%
    5
    22.7%
    Normal
    4
    36.4%
    5
    22.7%
    Abnormal
    5
    45.5%
    4
    18.2%
    45. Secondary Outcome
    Title Shift Table of the Change in Parotid Technetium Scan at Study Day 56 From Stage II Screening Visit
    Description Change in the evaluations of the parotid technetium scans at Study Day 56 from Stage II Screening Visit. Possible technetium scan evaluations at both Baseline and Study Day 56 include: Normal; Abnormal.
    Time Frame Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
    Arm/Group Title Dexamethasone Irrigation of Parotid Gland Placebo Irrigation of Parotid Gland
    Arm/Group Description Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28. Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
    Measure Participants 9 9
    Screening Normal; Study Day 56 Normal
    4
    36.4%
    4
    18.2%
    Baseline Normal; Study Day 56 Abnormal
    0
    0%
    0
    0%
    Baseline Abnormal; Study Day 56 Normal
    0
    0%
    1
    4.5%
    Baseline Abnormal; Study Day 56 Abnormal
    5
    45.5%
    4
    18.2%
    46. Secondary Outcome
    Title Summary Statistics of Focus Score
    Description Focus score is the number of mononuclear cell infiltrates containing at least 50 inflammatory cells in a 4 mm² glandular section. Focus scores ≥1 are key criteria used in the diagnosis of inflammation in the oral component of Sjögren's Syndrome. Higher numbers are associated with more inflammation. (Range 0-12).
    Time Frame Stage II screening (within 6 wks before baseline) through 56 days post-baseline

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP). Since only the right parotid was biopsied, 9 parotids were biopsied (5 dexamethasone and 4 placebo randomized parotids). At Screening only 4/5 dexamethasone and 4/4 placebo randomized parotids were biopsied. At Study Day 56 only 3/5 dexamethasone and 4/4 placebo randomized parotids were biopsied.
    Arm/Group Title Dexamethasone Irrigation of Parotid Gland Placebo Irrigation of Parotid Gland
    Arm/Group Description Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28. Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
    Measure Participants 4 4
    Measure Parotid gland on right side of mouth 4 4
    Stage II Screening
    2.5
    1.5
    Study Day 56
    1
    0.5
    47. Secondary Outcome
    Title Shift Table of Focus Scores From Stage II Screening to Study Day 56
    Description Focus score is the number of mononuclear cell infiltrates containing at least 50 inflammatory cells in a 4 mm² glandular section. Table data are the shift in focus score from Stage II Screening to Study Day 56. Only shift table cells with more than 0 participants were included in the Outcome Measure Data Table below.
    Time Frame Stage II Screening (within 6 wks before baseline) through 56 days post-baseline

    Outcome Measure Data

    Analysis Population Description
    Secondary Efficacy Population (SEP). Since only the right parotid was biopsied, 9 parotids were biopsied (5 dexamethasone and 4 placebo randomized parotids). At Screening only 4/5 dexamethasone and 4/4 placebo randomized parotids were biopsied. At Study Day 56 only 3/5 dexamethasone and 4/4 placebo randomized parotids were biopsied.
    Arm/Group Title Dexamethasone Irrigation of Parotid Gland Placebo Irrigation of Parotid Gland
    Arm/Group Description Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28. Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
    Measure Participants 5 4
    Screening Focus=0; Day 56 Focus=0
    0
    0%
    1
    4.5%
    Screening Focus=1; Day 56 Focus=1
    1
    9.1%
    1
    4.5%
    Screening Focus=2; Day 56 Focus=0
    1
    9.1%
    1
    4.5%
    Screening Focus=2; Day 56 Focus=5
    0
    0%
    1
    4.5%
    Screening Focus=3; Day 56 Focus=not done
    1
    9.1%
    0
    0%
    Screening Focus=12; Day 56 Focus=3
    1
    9.1%
    0
    0%
    Screening Focus=not done; Day 56 Focus=not done
    1
    9.1%
    0
    0%

    Adverse Events

    Time Frame Treatment emergent adverse events (AEs) are being reported in this document. Reporting period was 71 days from Randomization (Study Day 0) through Safety Follow-up (71 days).
    Adverse Event Reporting Description Adverse events were graded according to a descriptive scale based on the NIAID Division of Acquired Immunodeficiency Syndrome Table for Grading the Severity of Adverse Events. Adverse events were summarized by parotid treatment when related to the side of the mouth of parotid irrigation; otherwise, adverse events were summarized as not related to side of the mouth.
    Arm/Group Title Dexamethasone Irrigation Placebo Irrigation Side of Mouth Not Applicable
    Arm/Group Description Adverse event from the side of the mouth that received the parotid dexamethasone irrigation Adverse event from the side of the mouth that received the parotid placebo irrigation Side of mouth is not applicable to the adverse event
    All Cause Mortality
    Dexamethasone Irrigation Placebo Irrigation Side of Mouth Not Applicable
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/9 (0%) 0/9 (0%) 0/9 (0%)
    Serious Adverse Events
    Dexamethasone Irrigation Placebo Irrigation Side of Mouth Not Applicable
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/9 (0%) 0/9 (0%) 0/9 (0%)
    Other (Not Including Serious) Adverse Events
    Dexamethasone Irrigation Placebo Irrigation Side of Mouth Not Applicable
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/9 (22.2%) 2/9 (22.2%) 5/9 (55.6%)
    Ear and labyrinth disorders
    Vertigo 0/9 (0%) 0 0/9 (0%) 0 1/9 (11.1%) 1
    Gastrointestinal disorders
    Constipation 0/9 (0%) 0 0/9 (0%) 0 1/9 (11.1%) 1
    Parotid gland enlargement 0/9 (0%) 0 2/9 (22.2%) 2 0/9 (0%) 0
    Investigations
    Hepatic enzyme increased 0/9 (0%) 0 0/9 (0%) 0 1/9 (11.1%) 1
    Nervous system disorders
    Aphonia 0/9 (0%) 0 0/9 (0%) 0 1/9 (11.1%) 1
    Dysgeusia 0/9 (0%) 0 0/9 (0%) 0 1/9 (11.1%) 1
    Headache 1/9 (11.1%) 1 0/9 (0%) 0 0/9 (0%) 0
    Migraine 0/9 (0%) 0 0/9 (0%) 0 1/9 (11.1%) 1
    Skin and subcutaneous tissue disorders
    Ecchymosis 1/9 (11.1%) 1 0/9 (0%) 0 0/9 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Ilias Alevizos
    Organization NIDCR/NIH
    Phone 3014966207
    Email alevizosi@mail.nih.gov
    Responsible Party:
    National Institute of Dental and Craniofacial Research (NIDCR)
    ClinicalTrials.gov Identifier:
    NCT01316770
    Other Study ID Numbers:
    • 110094
    • 11-D-0094
    First Posted:
    Mar 16, 2011
    Last Update Posted:
    Nov 2, 2018
    Last Verified:
    Nov 1, 2018