Sjögren's Syndrome, Xerostomia
Conditions
Keywords
Xerostomia, Sjögren's Syndrome, Interventional Study, Sjogren's Syndrome, Dry Mouth
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.
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.
Interventions
DRUGDexamethasone Parotid Irrigation
Irrigation of the parotid gland from one side of the mouth with dexamethasone.
DRUGPlacebo Parotid Irrigation
Irrigation of the parotid gland on the opposite side of the mouth with placebo saline.
Sponsors
National Institute of Dental and Craniofacial Research (NIDCR)
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* INCLUSION CRITERIA: * Female gender and age 18 and greater. * Diagnosed with primary SS in Protocol 84-D-0056. * Stimulated salivary flow of at least 0.01 mL/min from each parotid gland, using the standard operating procedure (SOP) for the National Institute of Dental and Craniofacial Research (NIDCR) Molecular Physiology and Therapeutics Branch (MPTB) Sjögren's Syndrome Clinic * Minor salivary gland (MSG) biopsy with a focus score of greater than or equal to 1 obtained 0 to 7 years prior to study enrollment. Biopsies from outside of the National Institutes of Health (NIH) must be reviewed by the NIH Pathology Department. An MSG biopsy will be required for the following situations: * The last biopsy was obtained before the use of rituximab. * The last biopsy was obtained before the use of immunosuppressants, biologics, or disease-modifying antirheumatic drugs for more than 3 months. * The last biopsy was obtained before the use of systemic corticosteroids (for more than 2 weeks or for shorter periods at doses of more than 0.5 mg/kg) or local parotid corticosteroids. The use of topical or intra-articular/periarticular corticosteroids will not require a repeat biopsy. * For women of childbearing potential, use of, or willingness to use, an effective method of birth control during the study. Effective methods include abstinence, history of hysterectomy, tubal ligation, intrauterine device, licensed hormonal methods, condoms, diaphragm, and cervical cap. * Ability to provide written informed consent prior to entry in the study.
Exclusion criteria
* History of lymphoma. * History of mycosis, aspergillosis, or other deep fungal infection of the parotid gland. * History of salivary gland malignancy (primary or metastatic to the salivary gland). * History of secondary Sjögren's syndrome. * Parotid infection that does not resolve at least 4 weeks before the start of the Screening Period. * Any active viral infection that does not resolve by the start of the Screening Period. * Pregnancy or lactation. * Use of biologics within 3 months of the start of the Screening Period. * Any experimental therapy within 3 months before the start of the Screening Period. * Use of immunosuppressants such as methotrexate, leflunomide, azathioprine, cyclophosphamide, systemic cyclosporine, or systemic corticosteroids within 3 months prior to the start of the Screening Period. * Use of inhaled corticosteroids within 3 months prior to the start of the Screening Period. * Use of antimalarials and regular use of NSAIDs unless the dose has been stable (or decreased) for at least 2 months. * Inability to discontinue the use of saliva stimulants such as pilocarpine and cevimeline for 24 hours before each study visit. * Parotid intraductal irrigation or instillation with steroids within the past year. * Use of rituximab within 6 months prior to the start of the Screening Period. * Allergy to steroids or technetium, or any components of the formulations. * Current use of warfarin or heparin. * History of bleeding disorder. * Both severe atrophy and fibrosis of the MSG noted on the pathology report of the MSG biopsy. * Inability to comply with protocol procedures and the number of required visits. * Inability to cannulate one or both parotid glands. * Parotid fill volume less than 0.5 mL in one or both parotid glands. * Significant concurrent medical condition or other circumstances that, in the opinion of the principal investigator, could affect the subject's ability to tolerate or complete the study. * Unable to understand written English for completion of study questionnaires.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| 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. |
| 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. |
| 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 |
| 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. |
| 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. |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| 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 |
| 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 |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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). |
| 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. |
| 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). |
Countries
United States
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Safety Population: all enrolled participants that received any parotid saline irrigation used to determine parotid filling volume during Stage I screening. | 11 |
| Overall Study Safety Population: all enrolled participants that received any parotid saline irrigation used to determine parotid filling volume during Stage I screening. | 22 |
| Total | 33 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Customized Age Category 18-30 years | 0 Participants |
| Age, Customized Age Category 31-40 years | 2 Participants |
| Age, Customized Age Category 41-50 years | 1 Participants |
| Age, Customized Age Category 51-60 years | 6 Participants |
| Age, Customized Age Category 61-65 years | 1 Participants |
| Age, Customized Age Category 66-70 years | 0 Participants |
| Age, Customized Age Category Missing | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Focus Score Parotid randomized to dexamethasone irrigation | 2.5 score on a scale |
| Focus Score Parotid randomized to placebo irrigation | 1.5 score on a scale |
| Height | 158.68 cm |
| MRI Scan Evaluation Not randomized, left-side parotid Abnormal cs | 0 parotid glands |
| MRI Scan Evaluation Not randomized, left-side parotid Abnormal ncs | 0 parotid glands |
| MRI Scan Evaluation Not randomized, left-side parotid Normal | 0 parotid glands |
| MRI Scan Evaluation Not randomized, left-side parotid Not done | 2 parotid glands |
| MRI Scan Evaluation Not randomized, right-side parotid Abnormal cs | 0 parotid glands |
| MRI Scan Evaluation Not randomized, right-side parotid Abnormal ncs | 0 parotid glands |
| MRI Scan Evaluation Not randomized, right-side parotid Normal | 0 parotid glands |
| MRI Scan Evaluation Not randomized, right-side parotid Not done | 2 parotid glands |
| MRI Scan Evaluation Parotid randomized to dexamethasone irrigation Abnormal cs | 0 parotid glands |
| MRI Scan Evaluation Parotid randomized to dexamethasone irrigation Abnormal ncs | 4 parotid glands |
| MRI Scan Evaluation Parotid randomized to dexamethasone irrigation Normal | 5 parotid glands |
| MRI Scan Evaluation Parotid randomized to dexamethasone irrigation Not done | 0 parotid glands |
| MRI Scan Evaluation Parotid randomized to placebo irrigation Abnormal cs | 0 parotid glands |
| MRI Scan Evaluation Parotid randomized to placebo irrigation Abnormal ncs | 4 parotid glands |
| MRI Scan Evaluation Parotid randomized to placebo irrigation Normal | 5 parotid glands |
| MRI Scan Evaluation Parotid randomized to placebo irrigation Not done | 0 parotid glands |
| Parotid Fill Volume Not randomized, left-side parotid | 0.875 mL/min |
| Parotid Fill Volume Not randomized, right-side parotid | 0.875 mL/min |
| Parotid Fill Volume Parotid randomized to dexamethasone irrigation | 1.0 mL/min |
| Parotid Fill Volume Parotid randomized to placebo irrigation | 1.0 mL/min |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 11 Participants |
| Saliva Flow Parotid randomized to dexamethasone irrigation | 0.21250 mL/min STANDARD_DEVIATION 0.15885 |
| Saliva Flow Parotid randomized to placebo irrigation | 0.19096 mL/min STANDARD_DEVIATION 0.136399 |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 0 Participants |
| Technetium Isotope Uptake Not randomized, left-side parotid No | 0 parotid glands |
| Technetium Isotope Uptake Not randomized, left-side parotid Not done | 1 parotid glands |
| Technetium Isotope Uptake Not randomized, left-side parotid Yes | 1 parotid glands |
| Technetium Isotope Uptake Not randomized, right-side parotid No | 0 parotid glands |
| Technetium Isotope Uptake Not randomized, right-side parotid Not done | 1 parotid glands |
| Technetium Isotope Uptake Not randomized, right-side parotid Yes | 1 parotid glands |
| Technetium Isotope Uptake Parotid randomized to dexamethasone irrigation No | 0 parotid glands |
| Technetium Isotope Uptake Parotid randomized to dexamethasone irrigation Not done | 0 parotid glands |
| Technetium Isotope Uptake Parotid randomized to dexamethasone irrigation Yes | 9 parotid glands |
| Technetium Isotope Uptake Parotid randomized to placebo irrigation No | 0 parotid glands |
| Technetium Isotope Uptake Parotid randomized to placebo irrigation Not done | 0 parotid glands |
| Technetium Isotope Uptake Parotid randomized to placebo irrigation Yes | 9 parotid glands |
| Technetium Release with Stimulation Not randomized, left-side parotid No | 0 parotid glands |
| Technetium Release with Stimulation Not randomized, left-side parotid Not done | 1 parotid glands |
| Technetium Release with Stimulation Not randomized, left-side parotid Yes | 1 parotid glands |
| Technetium Release with Stimulation Not randomized, right-side parotid No | 0 parotid glands |
| Technetium Release with Stimulation Not randomized, right-side parotid Not done | 1 parotid glands |
| Technetium Release with Stimulation Not randomized, right-side parotid Yes | 1 parotid glands |
| Technetium Release with Stimulation Parotid randomized to dexamethasone irrigation No | 1 parotid glands |
| Technetium Release with Stimulation Parotid randomized to dexamethasone irrigation Not done | 0 parotid glands |
| Technetium Release with Stimulation Parotid randomized to dexamethasone irrigation Yes | 8 parotid glands |
| Technetium Release with Stimulation Parotid randomized to placebo irrigation No | 2 parotid glands |
| Technetium Release with Stimulation Parotid randomized to placebo irrigation Not done | 0 parotid glands |
| Technetium Release with Stimulation Parotid randomized to placebo irrigation Yes | 7 parotid glands |
| Technetium Scan Evaluation Not randomized, left-side parotid Abnormal | 1 parotid glands |
| Technetium Scan Evaluation Not randomized, left-side parotid Normal | 0 parotid glands |
| Technetium Scan Evaluation Not randomized, left-side parotid Not done | 1 parotid glands |
| Technetium Scan Evaluation Not randomized, right-side parotid Abnormal | 1 parotid glands |
| Technetium Scan Evaluation Not randomized, right-side parotid Normal | 0 parotid glands |
| Technetium Scan Evaluation Not randomized, right-side parotid Not done | 1 parotid glands |
| Technetium Scan Evaluation Parotid randomized to dexamethasone irrigation Abnormal | 5 parotid glands |
| Technetium Scan Evaluation Parotid randomized to dexamethasone irrigation Normal | 4 parotid glands |
| Technetium Scan Evaluation Parotid randomized to dexamethasone irrigation Not done | 0 parotid glands |
| Technetium Scan Evaluation Placebo randomized parotid: Normal Abnormal | 5 parotid glands |
| Technetium Scan Evaluation Placebo randomized parotid: Normal Normal | 4 parotid glands |
| Technetium Scan Evaluation Placebo randomized parotid: Normal Not done | 0 parotid glands |
| Waist Circumference | 98.0 cm |
| Weight | 68.95 kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 2 / 9 | 2 / 9 | 5 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 | 0 / 9 |
Outcome results
Primary
Change in Parotid Salivary Flow From Baseline (Day 0) to Day 56.
Saliva flow rate was determined by weighing the saliva flow collected separately from each parotid (dexamethasone irrigated and placebo irrigated parotid) within a participant and dividing by collection time. Saliva was collected using a Teflon collection cup placed over the parotid duct orifice and held in place by slight negative pressure. Collection time was 1 minute. The primary outcome measure is looking at change from baseline at Study Day 56 and not the flow at any particular time.
Time frame: Baseline (Study Day 0) to Study Day 56
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Change in Parotid Salivary Flow From Baseline (Day 0) to Day 56. | -0.01120 g/min | Standard Error 0.049063 |
| Placebo Irrigation of Parotid Gland | Change in Parotid Salivary Flow From Baseline (Day 0) to Day 56. | -0.05204 g/min | Standard Error 0.032029 |
Comparison: 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.p-value: 0.236one-sided Paired t-test
Secondary
Change in Parotid Salivary Flow From Baseline (Day 0) to Day 28.
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Change in Parotid Salivary Flow From Baseline (Day 0) to Day 28. | -0.09808 g/min | Standard Error 0.05896 |
| Placebo Irrigation of Parotid Gland | Change in Parotid Salivary Flow From Baseline (Day 0) to Day 28. | -0.06678 g/min | Standard Error 0.071649 |
Comparison: 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.p-value: 0.607one-sided paired t-test
Secondary
Change in Parotid Salivary Flow From Baseline (Day 0) to Day 42.
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Change in Parotid Salivary Flow From Baseline (Day 0) to Day 42. | 0.00224 g/min | Standard Deviation 0.055472 |
| Placebo Irrigation of Parotid Gland | Change in Parotid Salivary Flow From Baseline (Day 0) to Day 42. | 0.01192 g/min | Standard Deviation 0.031049 |
Comparison: 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.p-value: 0.586one-sided paired t-test
Secondary
Change in Parotid Salivary Flow From Baseline (Study Day 0) to Study Day 14.
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Change in Parotid Salivary Flow From Baseline (Study Day 0) to Study Day 14. | -0.01106 g/min | Standard Error 0.075004 |
| Placebo Irrigation of Parotid Gland | Change in Parotid Salivary Flow From Baseline (Study Day 0) to Study Day 14. | 0.01875 g/min | Standard Error 0.047825 |
Comparison: 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.p-value: 0.662one-sided paired t-test
Secondary
Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be:
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
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: | Stage II Screening | Too much | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: | Stage II Screening | Do not notice it | 5 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: | Study Day 14 | Too little | 6 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: | Study Day 42 | Too much | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: | Study Day 42 | Do not notice it | 4 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: | Study Day 56 | Too little | 4 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: | Stage II Screening | Too little | 4 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: | Study Day 14 | Too much | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: | Study Day 14 | Do not notice it | 3 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: | Study Day 28 | Too little | 5 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: | Study Day 28 | Too much | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: | Study Day 28 | Do not notice it | 4 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: | Study Day 42 | Too little | 5 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: | Study Day 56 | Too much | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: | Study Day 56 | Do not notice it | 5 Participants |
Secondary
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study?
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
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? | Study Day 14 | Yes | 5 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? | Study Day 14 | No | 3 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? | Stage II Screening | Yes | 3 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? | Stage II Screening | No | 6 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? | Stage II Screening | Not Sure | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? | Study Day 14 | Not Sure | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? | Study Day 28 | Yes | 3 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? | Study Day 28 | No | 5 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? | Study Day 28 | Not Sure | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? | Study Day 42 | Yes | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? | Study Day 42 | No | 5 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? | Study Day 42 | Not Sure | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? | Study Day 56 | Yes | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? | Study Day 56 | No | 6 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? | Study Day 56 | Not Sure | 1 Participants |
Secondary
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study?
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
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? | Stage II Screening | Not Sure | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? | Study Day 14 | Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? | Stage II Screening | Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? | Stage II Screening | No | 6 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? | Study Day 14 | No | 7 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? | Study Day 14 | Not Sure | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? | Study Day 28 | Yes | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? | Study Day 28 | No | 7 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? | Study Day 28 | Not Sure | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? | Study Day 42 | Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? | Study Day 42 | No | 8 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? | Study Day 42 | Not Sure | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? | Study Day 56 | Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? | Study Day 56 | No | 7 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? | Study Day 56 | Not Sure | 1 Participants |
Secondary
Patient Dry Mouth Questionnaire: Do You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study?
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
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Do You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study? | Stage II Screening | Yes | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Do You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study? | Stage II Screening | No | 7 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Do You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study? | Study Day 14 | Yes | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Do You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study? | Study Day 14 | No | 7 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Do You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study? | Study Day 28 | Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Do You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study? | Study Day 28 | No | 8 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Do You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study? | Study Day 42 | Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Do You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study? | Study Day 42 | No | 8 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Do You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study? | Study Day 56 | Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Do You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study? | Study Day 56 | No | 8 Participants |
Secondary
Patient Dry Mouth Questionnaire: Do You Have More Difficulty Swallowing Dry Foods Without Additional Liquids Since Starting the Study?
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
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Do You Have More Difficulty Swallowing Dry Foods Without Additional Liquids Since Starting the Study? | Study Day 56 | Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Do You Have More Difficulty Swallowing Dry Foods Without Additional Liquids Since Starting the Study? | Study Day 56 | No | 8 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Do You Have More Difficulty Swallowing Dry Foods Without Additional Liquids Since Starting the Study? | Stage II Screening | Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Do You Have More Difficulty Swallowing Dry Foods Without Additional Liquids Since Starting the Study? | Stage II Screening | No | 8 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Do You Have More Difficulty Swallowing Dry Foods Without Additional Liquids Since Starting the Study? | Study Day 14 | Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Do You Have More Difficulty Swallowing Dry Foods Without Additional Liquids Since Starting the Study? | Study Day 14 | No | 8 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Do You Have More Difficulty Swallowing Dry Foods Without Additional Liquids Since Starting the Study? | Study Day 28 | Yes | 3 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Do You Have More Difficulty Swallowing Dry Foods Without Additional Liquids Since Starting the Study? | Study Day 28 | No | 6 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Do You Have More Difficulty Swallowing Dry Foods Without Additional Liquids Since Starting the Study? | Study Day 42 | Yes | 3 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Do You Have More Difficulty Swallowing Dry Foods Without Additional Liquids Since Starting the Study? | Study Day 42 | No | 6 Participants |
Secondary
Patient Dry Mouth Questionnaire: Do You Use Anything to Keep Your Mouth Moist?
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
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Do You Use Anything to Keep Your Mouth Moist? | Stage II Screening | Yes | 8 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Do You Use Anything to Keep Your Mouth Moist? | Study Day 42 | Yes | 9 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Do You Use Anything to Keep Your Mouth Moist? | Study Day 42 | No | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Do You Use Anything to Keep Your Mouth Moist? | Study Day 56 | Yes | 8 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Do You Use Anything to Keep Your Mouth Moist? | Study Day 56 | No | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Do You Use Anything to Keep Your Mouth Moist? | Stage II Screening | No | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Do You Use Anything to Keep Your Mouth Moist? | Study Day 14 | Yes | 9 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Do You Use Anything to Keep Your Mouth Moist? | Study Day 14 | No | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Do You Use Anything to Keep Your Mouth Moist? | Study Day 28 | Yes | 9 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Do You Use Anything to Keep Your Mouth Moist? | Study Day 28 | No | 0 Participants |
Secondary
Patient Dry Mouth Questionnaire: Have You Experienced Any Changes in Your Sense of Taste Since Starting the Study?
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
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Have You Experienced Any Changes in Your Sense of Taste Since Starting the Study? | Stage II Screening | Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Have You Experienced Any Changes in Your Sense of Taste Since Starting the Study? | Stage II Screening | No | 8 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Have You Experienced Any Changes in Your Sense of Taste Since Starting the Study? | Study Day 14 | Yes | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Have You Experienced Any Changes in Your Sense of Taste Since Starting the Study? | Study Day 14 | No | 7 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Have You Experienced Any Changes in Your Sense of Taste Since Starting the Study? | Study Day 28 | Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Have You Experienced Any Changes in Your Sense of Taste Since Starting the Study? | Study Day 28 | No | 8 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Have You Experienced Any Changes in Your Sense of Taste Since Starting the Study? | Study Day 42 | Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Have You Experienced Any Changes in Your Sense of Taste Since Starting the Study? | Study Day 42 | No | 9 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Have You Experienced Any Changes in Your Sense of Taste Since Starting the Study? | Study Day 56 | Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: Have You Experienced Any Changes in Your Sense of Taste Since Starting the Study? | Study Day 56 | No | 9 Participants |
Secondary
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:
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
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | 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: | Study Day 14 | I have gum pain | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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: | Study Day 28 | I have tooth pain | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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: | Study Day 28 | I have gum pain | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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: | Study Day 28 | I have pain in my jaws or TMJ | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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: | Study Day 56 | I have pain in my jaws or TMJ | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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: | Stage II Screening | Mouth or tongue burns | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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: | Stage II Screening | I have tooth pain | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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: | Stage II Screening | I have gum pain | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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: | Stage II Screening | I have pain in my jaws or TMJ | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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: | Study Day 14 | Mouth or tongue burns | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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: | Study Day 14 | I have tooth pain | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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: | Study Day 14 | I have pain in my jaws or TMJ | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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: | Study Day 28 | Mouth or tongue burns | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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: | Study Day 42 | Mouth or tongue burns | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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: | Study Day 42 | I have tooth pain | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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: | Study Day 42 | I have gum pain | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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: | Study Day 42 | I have pain in my jaws or TMJ | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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: | Study Day 56 | Mouth or tongue burns | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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: | Study Day 56 | I have tooth pain | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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: | Study Day 56 | I have gum pain | 0 Participants |
Secondary
Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify:
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
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: | Stage II Screening | Foods taste less intense (for example, less sweet) | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: | Stage II Screening | Foods taste more intense (for example, more sweet) | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: | Stage II Screening | I have persistent bad taste in my mouth | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: | Study Day 14 | Foods taste different than they used to | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: | Study Day 14 | Foods taste less intense (for example, less sweet) | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: | Study Day 28 | Foods taste more intense (for example, more sweet) | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: | Study Day 28 | I have persistent bad taste in my mouth | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: | Stage II Screening | Foods taste different than they used to | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: | Study Day 14 | Foods taste more intense (for example, more sweet) | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: | Study Day 14 | I have persistent bad taste in my mouth | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: | Study Day 28 | Foods taste different than they used to | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: | Study Day 28 | Foods taste less intense (for example, less sweet) | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: | Study Day 42 | Foods taste different than they used to | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: | Study Day 42 | Foods taste less intense (for example, less sweet) | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: | Study Day 42 | Foods taste more intense (for example, more sweet) | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: | Study Day 42 | I have persistent bad taste in my mouth | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: | Study Day 56 | Foods taste different than they used to | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: | Study Day 56 | Foods taste less intense (for example, less sweet) | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: | Study Day 56 | Foods taste more intense (for example, more sweet) | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: | Study Day 56 | I have persistent bad taste in my mouth | 0 Participants |
Secondary
Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify:
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: | Study Day 14: use commercial products | 3 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: | Study Day 14: Chew sugared gum or mints | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: | Study Day 14: Chew sugarless gum or mints | 4 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: | Study Day 28: Sip water | 8 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: | Study Day 28: Sip liquids other than water | 7 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: | Study Day 28: use commercial products | 4 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: | Study Day 28: Chew sugared gum or mints | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: | Study Day 28: Chew sugarless gum or mints | 3 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: | Study Day 42: Chew sugarless gum or mints | 3 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: | Baseline: Sip water | 8 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: | Baseline: Sip liquids other than water | 6 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: | Baseline: use commercial products | 4 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: | Baseline: Chew sugared gum or mints | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: | Baseline: Chew sugarless gum or mints | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: | Study Day 14: Sip water | 8 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: | Study Day 14: Sip liquids other than water | 6 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: | Study Day 42: Sip water | 7 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: | Study Day 42: Sip liquids other than water | 5 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: | Study Day 42: use commercial products | 3 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: | Study Day 42: Chew sugared gum or mints | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: | Study Day 56: Sip water | 8 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: | Study Day 56: Sip liquids other than water | 3 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: | Study Day 56: use commercial products | 3 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: | Study Day 56: Chew sugared gum or mints | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: | Study Day 56: Chew sugarless gum or mints | 2 Participants |
Secondary
Patient Dry Mouth Questionnaire. Question: Do You Have More Difficulty Chewing Your Food Since Starting the Study?
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
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: Do You Have More Difficulty Chewing Your Food Since Starting the Study? | Study Day 42 | No | 8 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: Do You Have More Difficulty Chewing Your Food Since Starting the Study? | Study Day 56 | Yes | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: Do You Have More Difficulty Chewing Your Food Since Starting the Study? | Study Day 56 | No | 7 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: Do You Have More Difficulty Chewing Your Food Since Starting the Study? | Stage II Screening | Yes | 3 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: Do You Have More Difficulty Chewing Your Food Since Starting the Study? | Stage II Screening | No | 6 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: Do You Have More Difficulty Chewing Your Food Since Starting the Study? | Study Day 14 | Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: Do You Have More Difficulty Chewing Your Food Since Starting the Study? | Study Day 14 | No | 8 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: Do You Have More Difficulty Chewing Your Food Since Starting the Study? | Study Day 28 | Yes | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: Do You Have More Difficulty Chewing Your Food Since Starting the Study? | Study Day 28 | No | 7 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: Do You Have More Difficulty Chewing Your Food Since Starting the Study? | Study Day 42 | Yes | 1 Participants |
Secondary
Patient Dry Mouth Questionnaire. Question: Have You Experienced Any Changes in Your Sense of Smell Since Starting the Study?
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
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: Have You Experienced Any Changes in Your Sense of Smell Since Starting the Study? | Study Day 14 | No | 9 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: Have You Experienced Any Changes in Your Sense of Smell Since Starting the Study? | Stage II Screening | Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: Have You Experienced Any Changes in Your Sense of Smell Since Starting the Study? | Stage II Screening | No | 9 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: Have You Experienced Any Changes in Your Sense of Smell Since Starting the Study? | Study Day 14 | Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: Have You Experienced Any Changes in Your Sense of Smell Since Starting the Study? | Study Day 28 | Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: Have You Experienced Any Changes in Your Sense of Smell Since Starting the Study? | Study Day 28 | No | 9 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: Have You Experienced Any Changes in Your Sense of Smell Since Starting the Study? | Study Day 42 | Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: Have You Experienced Any Changes in Your Sense of Smell Since Starting the Study? | Study Day 42 | No | 9 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: Have You Experienced Any Changes in Your Sense of Smell Since Starting the Study? | Study Day 56 | Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: Have You Experienced Any Changes in Your Sense of Smell Since Starting the Study? | Study Day 56 | No | 9 Participants |
Secondary
Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why?
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
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? | Study Day 14 | Too few Teeth | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? | Study Day 14 | Other | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? | Study Day 42 | Other | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? | Study Day 56 | Pain | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? | Stage II Screening | Pain | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? | Stage II Screening | Dryness | 3 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? | Stage II Screening | Weakness | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? | Stage II Screening | Too few Teeth | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? | Stage II Screening | Other | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? | Study Day 14 | Pain | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? | Study Day 14 | Dryness | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? | Study Day 14 | Weakness | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? | Study Day 28 | Pain | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? | Study Day 28 | Dryness | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? | Study Day 28 | Weakness | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? | Study Day 28 | Too few Teeth | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? | Study Day 28 | Other | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? | Study Day 42 | Pain | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? | Study Day 42 | Dryness | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? | Study Day 42 | Weakness | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? | Study Day 42 | Too few Teeth | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? | Study Day 56 | Dryness | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? | Study Day 56 | Weakness | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? | Study Day 56 | Too few Teeth | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? | Study Day 56 | Other | 0 Participants |
Secondary
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell?
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
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? | Study Day 14 | Screening II: Yes; Study Day: Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? | Study Day 14 | Screening II: Yes; Study Day: No | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? | Study Day 14 | Screening II: No; Study Day: Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? | Study Day 14 | Screening II: No; Study Day: No | 9 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? | Study Day 28 | Screening II: Yes; Study Day: Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? | Study Day 28 | Screening II: Yes; Study Day: No | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? | Study Day 28 | Screening II: No; Study Day: Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? | Study Day 28 | Screening II: No; Study Day: No | 9 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? | Study Day 42 | Screening II: Yes; Study Day: Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? | Study Day 42 | Screening II: Yes; Study Day: No | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? | Study Day 42 | Screening II: No; Study Day: Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? | Study Day 42 | Screening II: No; Study Day: No | 9 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? | Study Day 56 | Screening II: Yes; Study Day: Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? | Study Day 56 | Screening II: Yes; Study Day: No | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? | Study Day 56 | Screening II: No; Study Day: Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? | Study Day 56 | Screening II: No; Study Day: No | 9 Participants |
Secondary
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste?
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
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? | Study Day 14 | Screening II: Yes; Study Day: Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? | Study Day 14 | Screening II: Yes; Study Day: No | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? | Study Day 42 | Screening II: Yes; Study Day: No | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? | Study Day 42 | Screening II: No; Study Day: Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? | Study Day 14 | Screening II: No; Study Day: Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? | Study Day 14 | Screening II: No; Study Day: No | 7 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? | Study Day 28 | Screening II: Yes; Study Day: Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? | Study Day 28 | Screening II: Yes; Study Day: No | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? | Study Day 28 | Screening II: No; Study Day: Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? | Study Day 28 | Screening II: No; Study Day: No | 7 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? | Study Day 42 | Screening II: Yes; Study Day: Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? | Study Day 42 | Screening II: No; Study Day: No | 8 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? | Study Day 56 | Screening II: Yes; Study Day: Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? | Study Day 56 | Screening II: Yes; Study Day: No | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? | Study Day 56 | Screening II: No; Study Day: Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? | Study Day 56 | Screening II: No; Study Day: No | 8 Participants |
Comparison: 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.p-value: 1McNemar
Comparison: 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.p-value: 1McNemar
Secondary
Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids?
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
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? | Study Day 14 | Screening II: Yes; Study Day: Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? | Study Day 14 | Screening II: Yes; Study Day: No | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? | Study Day 14 | Screening II: No; Study Day: Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? | Study Day 14 | Screening II: No; Study Day: No | 7 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? | Study Day 28 | Screening II: Yes; Study Day: Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? | Study Day 28 | Screening II: Yes; Study Day: No | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? | Study Day 28 | Screening II: No; Study Day: Yes | 3 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? | Study Day 28 | Screening II: No; Study Day: No | 5 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? | Study Day 42 | Screening II: Yes; Study Day: Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? | Study Day 42 | Screening II: Yes; Study Day: No | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? | Study Day 42 | Screening II: No; Study Day: Yes | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? | Study Day 42 | Screening II: No; Study Day: No | 6 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? | Study Day 56 | Screening II: Yes; Study Day: Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? | Study Day 56 | Screening II: Yes; Study Day: No | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? | Study Day 56 | Screening II: No; Study Day: Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? | Study Day 56 | Screening II: No; Study Day: No | 7 Participants |
Comparison: 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.p-value: 1McNemar
Comparison: 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.p-value: 0.625McNemar
Comparison: 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.p-value: 0.5McNemar
Comparison: 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.p-value: 1McNemar
Secondary
Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food?
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
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? | Study Day 14 | Screening II: Yes; Study Day: Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? | Study Day 14 | Screening II: Yes; Study Day: No | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? | Study Day 14 | Screening II: No; Study Day: Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? | Study Day 14 | Screening II: No; Study Day: No | 6 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? | Study Day 28 | Screening II: Yes; Study Day: Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? | Study Day 28 | Screening II: Yes; Study Day: No | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? | Study Day 28 | Screening II: No; Study Day: Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? | Study Day 28 | Screening II: No; Study Day: No | 5 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? | Study Day 42 | Screening II: Yes; Study Day: Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? | Study Day 42 | Screening II: Yes; Study Day: No | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? | Study Day 42 | Screening II: No; Study Day: Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? | Study Day 42 | Screening II: No; Study Day: No | 6 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? | Study Day 56 | Screening II: Yes; Study Day: Yes | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? | Study Day 56 | Screening II: Yes; Study Day: No | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? | Study Day 56 | Screening II: No; Study Day: Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? | Study Day 56 | Screening II: No; Study Day: No | 6 Participants |
Comparison: 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.p-value: 0.5McNemar
Comparison: 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.p-value: 1McNemar
Comparison: 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.p-value: 0.5McNemar
Comparison: 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.p-value: 1McNemar
Secondary
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day?
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
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? | Study Day 42 | Screening II: Yes; Study Day: Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? | Study Day 56 | Screening II: No; Study Day: Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? | Study Day 56 | Screening II: No; Study Day: No | 5 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? | Study Day 14 | Screening II: Yes; Study Day: Yes | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? | Study Day 14 | Screening II: Yes; Study Day: No | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? | Study Day 14 | Screening II: No; Study Day: Yes | 3 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? | Study Day 14 | Screening II: No; Study Day: No | 3 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? | Study Day 28 | Screening II: Yes; Study Day: Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? | Study Day 28 | Screening II: Yes; Study Day: No | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? | Study Day 28 | Screening II: No; Study Day: Yes | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? | Study Day 28 | Screening II: No; Study Day: No | 4 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? | Study Day 42 | Screening II: Yes; Study Day: No | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? | Study Day 42 | Screening II: No; Study Day: Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? | Study Day 42 | Screening II: No; Study Day: No | 5 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? | Study Day 56 | Screening II: Yes; Study Day: Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? | Study Day 56 | Screening II: Yes; Study Day: No | 1 Participants |
Comparison: 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.p-value: 0.25McNemar
Comparison: 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.p-value: 1McNemar
Comparison: 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.p-value: 1McNemar
Comparison: 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.p-value: 1McNemar
Secondary
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat?
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
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? | Study Day 14 | Screening II: No; Study Day: Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? | Study Day 14 | Screening II: No; Study Day: No | 5 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? | Study Day 14 | Screening II: Yes; Study Day: Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? | Study Day 14 | Screening II: Yes; Study Day: No | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? | Study Day 28 | Screening II: Yes; Study Day: Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? | Study Day 28 | Screening II: Yes; Study Day: No | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? | Study Day 28 | Screening II: No; Study Day: Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? | Study Day 28 | Screening II: No; Study Day: No | 6 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? | Study Day 42 | Screening II: Yes; Study Day: Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? | Study Day 42 | Screening II: Yes; Study Day: No | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? | Study Day 42 | Screening II: No; Study Day: Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? | Study Day 42 | Screening II: No; Study Day: No | 6 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? | Study Day 56 | Screening II: Yes; Study Day: Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? | Study Day 56 | Screening II: Yes; Study Day: No | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? | Study Day 56 | Screening II: No; Study Day: Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? | Study Day 56 | Screening II: No; Study Day: No | 5 Participants |
Secondary
Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck?
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
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? | Study Day 42 | Screening II: No; Study Day: No | 7 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? | Study Day 56 | Screening II: Yes; Study Day: Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? | Study Day 14 | Screening II: Yes; Study Day: Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? | Study Day 14 | Screening II: Yes; Study Day: No | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? | Study Day 14 | Screening II: No; Study Day: Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? | Study Day 14 | Screening II: No; Study Day: No | 6 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? | Study Day 28 | Screening II: Yes; Study Day: Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? | Study Day 28 | Screening II: Yes; Study Day: No | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? | Study Day 28 | Screening II: No; Study Day: Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? | Study Day 28 | Screening II: No; Study Day: No | 7 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? | Study Day 42 | Screening II: Yes; Study Day: Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? | Study Day 42 | Screening II: Yes; Study Day: No | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? | Study Day 42 | Screening II: No; Study Day: Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? | Study Day 56 | Screening II: Yes; Study Day: No | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? | Study Day 56 | Screening II: No; Study Day: Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? | Study Day 56 | Screening II: No; Study Day: No | 7 Participants |
Comparison: 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.p-value: 1McNemar
Comparison: 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.p-value: 1McNemar
Comparison: 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.p-value: 1McNemar
Comparison: 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.p-value: 1McNemar
Secondary
Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist?
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
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? | Study Day 14 | Screening II: Yes; Study Day: No | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? | Study Day 14 | Screening II: No; Study Day: Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? | Study Day 56 | Screening II: No; Study Day: Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? | Study Day 14 | Screening II: Yes; Study Day: Yes | 8 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? | Study Day 14 | Screening II: No; Study Day: No | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? | Study Day 28 | Screening II: Yes; Study Day: Yes | 8 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? | Study Day 28 | Screening II: Yes; Study Day: No | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? | Study Day 28 | Screening II: No; Study Day: Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? | Study Day 28 | Screening II: No; Study Day: No | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? | Study Day 42 | Screening II: Yes; Study Day: Yes | 8 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? | Study Day 42 | Screening II: Yes; Study Day: No | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? | Study Day 42 | Screening II: No; Study Day: Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? | Study Day 42 | Screening II: No; Study Day: No | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? | Study Day 56 | Screening II: Yes; Study Day: Yes | 8 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? | Study Day 56 | Screening II: Yes; Study Day: No | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? | Study Day 56 | Screening II: No; Study Day: No | 1 Participants |
Secondary
Shift Table of Focus Scores From Stage II Screening to Study Day 56
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Shift Table of Focus Scores From Stage II Screening to Study Day 56 | Screening Focus=2; Day 56 Focus=0 | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Shift Table of Focus Scores From Stage II Screening to Study Day 56 | Screening Focus=3; Day 56 Focus=not done | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Shift Table of Focus Scores From Stage II Screening to Study Day 56 | Screening Focus=1; Day 56 Focus=1 | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Shift Table of Focus Scores From Stage II Screening to Study Day 56 | Screening Focus=12; Day 56 Focus=3 | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Shift Table of Focus Scores From Stage II Screening to Study Day 56 | Screening Focus=2; Day 56 Focus=5 | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Shift Table of Focus Scores From Stage II Screening to Study Day 56 | Screening Focus=not done; Day 56 Focus=not done | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Shift Table of Focus Scores From Stage II Screening to Study Day 56 | Screening Focus=0; Day 56 Focus=0 | 0 Participants |
| Placebo Irrigation of Parotid Gland | Shift Table of Focus Scores From Stage II Screening to Study Day 56 | Screening Focus=not done; Day 56 Focus=not done | 0 Participants |
| Placebo Irrigation of Parotid Gland | Shift Table of Focus Scores From Stage II Screening to Study Day 56 | Screening Focus=0; Day 56 Focus=0 | 1 Participants |
| Placebo Irrigation of Parotid Gland | Shift Table of Focus Scores From Stage II Screening to Study Day 56 | Screening Focus=1; Day 56 Focus=1 | 1 Participants |
| Placebo Irrigation of Parotid Gland | Shift Table of Focus Scores From Stage II Screening to Study Day 56 | Screening Focus=2; Day 56 Focus=0 | 1 Participants |
| Placebo Irrigation of Parotid Gland | Shift Table of Focus Scores From Stage II Screening to Study Day 56 | Screening Focus=2; Day 56 Focus=5 | 1 Participants |
| Placebo Irrigation of Parotid Gland | Shift Table of Focus Scores From Stage II Screening to Study Day 56 | Screening Focus=3; Day 56 Focus=not done | 0 Participants |
| Placebo Irrigation of Parotid Gland | Shift Table of Focus Scores From Stage II Screening to Study Day 56 | Screening Focus=12; Day 56 Focus=3 | 0 Participants |
Secondary
Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit
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
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit | Screening Normal; Study Day 56 Normal | 4 Participants |
| Dexamethasone Irrigation of Parotid Gland | Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit | Screening Abnormal ncs; Study Day 56 Abnormal ncs | 3 Participants |
| Dexamethasone Irrigation of Parotid Gland | Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit | Screening Normal; Study Day 56 Abnormal cs | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit | Screening Abnormal cs; Study Day 56 Normal | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit | Screening Normal; Study Day 56 Abnormal ncs | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit | Screening Abnormal cs; Study Day 56 Abnormal ncs | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit | Screening Abnormal ncs; Study Day 56 Normal | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit | Screening Abnormal cs; Study Day 56 Abnormal cs | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit | Screening Abnormal ncs; Study Day 56 Abnormal cs | 0 Participants |
| Placebo Irrigation of Parotid Gland | Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit | Screening Abnormal cs; Study Day 56 Abnormal cs | 0 Participants |
| Placebo Irrigation of Parotid Gland | Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit | Screening Abnormal ncs; Study Day 56 Abnormal cs | 0 Participants |
| Placebo Irrigation of Parotid Gland | Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit | Screening Normal; Study Day 56 Normal | 5 Participants |
| Placebo Irrigation of Parotid Gland | Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit | Screening Normal; Study Day 56 Abnormal ncs | 0 Participants |
| Placebo Irrigation of Parotid Gland | Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit | Screening Normal; Study Day 56 Abnormal cs | 0 Participants |
| Placebo Irrigation of Parotid Gland | Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit | Screening Abnormal ncs; Study Day 56 Normal | 1 Participants |
| Placebo Irrigation of Parotid Gland | Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit | Screening Abnormal ncs; Study Day 56 Abnormal ncs | 3 Participants |
| Placebo Irrigation of Parotid Gland | Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit | Screening Abnormal cs; Study Day 56 Normal | 0 Participants |
| Placebo Irrigation of Parotid Gland | Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit | Screening Abnormal cs; Study Day 56 Abnormal ncs | 0 Participants |
Secondary
Shift Table of the Change in Parotid Technetium Scan at Study Day 56 From Stage II Screening Visit
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
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Shift Table of the Change in Parotid Technetium Scan at Study Day 56 From Stage II Screening Visit | Screening Normal; Study Day 56 Normal | 4 Participants |
| Dexamethasone Irrigation of Parotid Gland | Shift Table of the Change in Parotid Technetium Scan at Study Day 56 From Stage II Screening Visit | Baseline Normal; Study Day 56 Abnormal | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Shift Table of the Change in Parotid Technetium Scan at Study Day 56 From Stage II Screening Visit | Baseline Abnormal; Study Day 56 Normal | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Shift Table of the Change in Parotid Technetium Scan at Study Day 56 From Stage II Screening Visit | Baseline Abnormal; Study Day 56 Abnormal | 5 Participants |
| Placebo Irrigation of Parotid Gland | Shift Table of the Change in Parotid Technetium Scan at Study Day 56 From Stage II Screening Visit | Baseline Abnormal; Study Day 56 Abnormal | 4 Participants |
| Placebo Irrigation of Parotid Gland | Shift Table of the Change in Parotid Technetium Scan at Study Day 56 From Stage II Screening Visit | Screening Normal; Study Day 56 Normal | 4 Participants |
| Placebo Irrigation of Parotid Gland | Shift Table of the Change in Parotid Technetium Scan at Study Day 56 From Stage II Screening Visit | Baseline Abnormal; Study Day 56 Normal | 1 Participants |
| Placebo Irrigation of Parotid Gland | Shift Table of the Change in Parotid Technetium Scan at Study Day 56 From Stage II Screening Visit | Baseline Normal; Study Day 56 Abnormal | 0 Participants |
Secondary
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):
Response: Yes; No
Time frame: Baseline (Study Day 0) through Study Day 56
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | 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 | Yes | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | No | 8 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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): | Study 14 | Yes | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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): | Study 14 | No | 7 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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): | Study Day 28 | Yes | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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): | Study Day 28 | No | 7 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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): | Study Day 42 | Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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): | Study Day 42 | No | 9 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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): | Study Day 56 | Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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): | Study Day 56 | No | 9 Participants |
Secondary
Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now:
Nominal Scale: Much better; Better; The same; Worse; Much worse
Time frame: Baseline (Study Day 0) through Study Day 56
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: | Study Day 14 | Much better | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: | Study Day 14 | Better | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: | Baseline | Much better | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: | Baseline | Better | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: | Baseline | The same | 7 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: | Baseline | Worse | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: | Baseline | Much worse | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: | Study Day 14 | The same | 7 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: | Study Day 14 | Worse | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: | Study Day 14 | Much worse | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: | Study Day 28 | Much better | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: | Study Day 28 | Better | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: | Study Day 28 | The same | 7 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: | Study Day 28 | Worse | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: | Study Day 28 | Much worse | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: | Study Day 42 | Much better | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: | Study Day 42 | Better | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: | Study Day 42 | The same | 9 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: | Study Day 42 | Worse | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: | Study Day 42 | Much worse | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: | Study Day 56 | Much better | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: | Study Day 56 | Better | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: | Study Day 56 | The same | 8 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: | Study Day 56 | Worse | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: | Study Day 56 | Much worse | 0 Participants |
Secondary
Sjögren's Disease Activity Index: Do You Consider Your Patient in a Satisfactory State of 'Minimal Disease Activity'?
Response: Yes or No
Time frame: Baseline (Study Day 0) through Study Day 56
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Do You Consider Your Patient in a Satisfactory State of 'Minimal Disease Activity'? | Baseline | Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Do You Consider Your Patient in a Satisfactory State of 'Minimal Disease Activity'? | Baseline | No | 9 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Do You Consider Your Patient in a Satisfactory State of 'Minimal Disease Activity'? | Study Day 14 | Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Do You Consider Your Patient in a Satisfactory State of 'Minimal Disease Activity'? | Study Day 14 | No | 9 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Do You Consider Your Patient in a Satisfactory State of 'Minimal Disease Activity'? | Study Day 28 | Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Do You Consider Your Patient in a Satisfactory State of 'Minimal Disease Activity'? | Study Day 28 | No | 9 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Do You Consider Your Patient in a Satisfactory State of 'Minimal Disease Activity'? | Study Day 42 | Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Do You Consider Your Patient in a Satisfactory State of 'Minimal Disease Activity'? | Study Day 42 | No | 9 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Do You Consider Your Patient in a Satisfactory State of 'Minimal Disease Activity'? | Study Day 56 | Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Do You Consider Your Patient in a Satisfactory State of 'Minimal Disease Activity'? | Study Day 56 | No | 9 Participants |
Secondary
Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale)
Nominal scale values: Inactive; Low; Moderate; High
Time frame: Baseline (Study Day 0) through Study Day 56
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) | Baseline | Inactive | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) | Baseline | Low | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) | Study Day 14 | Moderate | 7 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) | Study Day 14 | High | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) | Baseline | Moderate | 7 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) | Baseline | High | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) | Study Day 14 | Inactive | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) | Study Day 14 | Low | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) | Study Day 28 | Inactive | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) | Study Day 28 | Low | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) | Study Day 28 | Moderate | 7 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) | Study Day 28 | High | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) | Study Day 42 | Inactive | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) | Study Day 42 | Low | 3 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) | Study Day 42 | Moderate | 6 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) | Study Day 42 | High | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) | Study Day 56 | Inactive | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) | Study Day 56 | Low | 4 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) | Study Day 56 | Moderate | 5 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) | Study Day 56 | High | 0 Participants |
Secondary
Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Ordinal Numeric Scale)
Ordinal Scale 0:least to 10:greatest level of disease activity
Time frame: Baseline (Study Day 0) through Study Day 56
Population: 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 | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Ordinal Numeric Scale) | Baseline | 5 units on a scale |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Ordinal Numeric Scale) | Study Day 14 | 5 units on a scale |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Ordinal Numeric Scale) | Study Day 28 | 5 units on a scale |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Ordinal Numeric Scale) | Study Day 42 | 5 units on a scale |
| Dexamethasone Irrigation of Parotid Gland | Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Ordinal Numeric Scale) | Study Day 56 | 5 units on a scale |
Secondary
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
Ordinal Scale 0: least to 10: greatest level of disease activity.
Time frame: Baseline (Study Day 0) through Study Day 56
Population: 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 | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | 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 | 5 score on a scale |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 14 | 5 score on a scale |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 28 | 5 score on a scale |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 42 | 5 score on a scale |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 56 | 5 score on a scale |
Secondary
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.
Possible Response: Yes or No
Time frame: Baseline (Study Day 0) through Study Day 56
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | 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. | Study Day 14 | Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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. | Study Day 14 | No | 9 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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. | Study Day 28 | Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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. | Study Day 28 | No | 9 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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. | Study Day 42 | Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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. | Study Day 42 | No | 9 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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. | Study Day 56 | Yes | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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. | Study Day 56 | No | 9 Participants |
Secondary
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
Possible response on nominal scale: Inactive; Low; Moderate; High SDAI.
Time frame: Baseline (Study Day 0) to Study Day 56
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 14 | Baseline Low to Study Day Low | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 14 | Baseline Low to Study Day Moderate | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 14 | Baseline Low to Study Day High | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 14 | Baseline Moderate to Study Day High | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 14 | Baseline High to Study Day Inactive | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 28 | Baseline Inactive to Study Day Low | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 28 | Baseline Inactive to Study Day Moderate | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 28 | Baseline Inactive to Study Day High | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 28 | Baseline Low to Study Day Inactive | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 42 | Baseline Inactive to Study Day Inactive | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 42 | Baseline Inactive to Study Day Low | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 42 | Baseline Inactive to Study Day Moderate | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 42 | Baseline Low to Study Day Inactive | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 42 | Baseline Low to Study Day Low | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 42 | Baseline Low to Study Day Moderate | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 42 | Baseline Moderate to Study Day Low | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 42 | Baseline Moderate to Study Day Moderate | 6 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 42 | Baseline High to Study Day Low | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 42 | Baseline High to Study Day Moderate | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 42 | Baseline High to Study Day High | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 56 | Baseline Inactive to Study Day Low | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 56 | Baseline Inactive to Study Day Moderate | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 56 | Baseline Inactive to Study Day High | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 14 | Baseline Inactive to Study Day Inactive | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 14 | Baseline Inactive to Study Day Low | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 14 | Baseline Inactive to Study Day Moderate | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 14 | Baseline Inactive to Study Day High | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 14 | Baseline Low to Study Day Inactive | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 14 | Baseline Moderate to Study Day Inactive | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 14 | Baseline Moderate to Study Day Low | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 14 | Baseline Moderate to Study Day Moderate | 7 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 14 | Baseline High to Study Day Low | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 14 | Baseline High to Study Day Moderate | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 14 | Baseline High to Study Day High | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 28 | Baseline Inactive to Study Day Inactive | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 28 | Baseline Low to Study Day Low | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 28 | Baseline Low to Study Day Moderate | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 28 | Baseline Low to Study Day High | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 28 | Baseline Moderate to Study Day Inactive | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 28 | Baseline Moderate to Study Day Low | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 28 | Baseline Moderate to Study Day Moderate | 7 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 28 | Baseline Moderate to Study Day High | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 28 | Baseline High to Study Day Inactive | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 28 | Baseline High to Study Day Low | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 28 | Baseline High to Study Day Moderate | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 28 | Baseline High to Study Day High | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 42 | Baseline Inactive to Study Day High | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 42 | Baseline Low to Study Day High | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 42 | Baseline Moderate to Study Day Inactive | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 42 | Baseline Moderate to Study Day High | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 42 | Baseline High to Study Day Inactive | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 56 | Baseline Inactive to Study Day Inactive | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 56 | Baseline Low to Study Day Inactive | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 56 | Baseline Low to Study Day Low | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 56 | Baseline Low to Study Day Moderate | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 56 | Baseline Low to Study Day High | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 56 | Baseline Moderate to Study Day Inactive | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 56 | Baseline Moderate to Study Day Low | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 56 | Baseline Moderate to Study Day Moderate | 5 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 56 | Baseline Moderate to Study Day High | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 56 | Baseline High to Study Day Inactive | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 56 | Baseline High to Study Day Low | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 56 | Baseline High to Study Day Moderate | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 | Study Day 56 | Baseline High to Study Day High | 0 Participants |
Secondary
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
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
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | 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 SDAI=6; Study Day 14 SDAI=5 | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 SDAI=6; Study Day 14 SDAI=7 | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 SDAI=4; Study Day 14 SDAI=4 | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 SDAI=5; Study Day 14 SDAI=5 | 4 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 SDAI=7; Study Day 14 SDAI=7 | 1 Participants |
Secondary
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
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
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | 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 SDAI=4; Study Day 28 SDAI=4 | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 SDAI=5; Study Day 28 SDAI=5 | 4 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 SDAI=6; Study Day 28 SDAI=5 | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 SDAI=6; Study Day 28 SDAI=7 | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 SDAI=7; Study Day 28 SDAI=7 | 1 Participants |
Secondary
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
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
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | 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 SDAI=4; Study Day 42 SDAI=5 | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 SDAI=5; Study Day 42 SDAI=5 | 4 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 SDAI=6; Study Day 42 SDAI=5 | 3 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 SDAI=7; Study Day 42 SDAI=7 | 1 Participants |
Secondary
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
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
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | 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 SDAI=4; Study Day 56 SDAI=5 | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 SDAI=5; Study Day 56 SDAI=5 | 4 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 SDAI=6; Study Day 56 SDAI=5 | 3 Participants |
| Dexamethasone Irrigation of Parotid Gland | 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 SDAI=7; Study Day 56 SDAI=7 | 1 Participants |
Secondary
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 14 , Ordinal Scores
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
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 14 , Ordinal Scores | Baseline SDAI=5; Study Day 14 SDAI=5 | 4 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 14 , Ordinal Scores | Baseline SDAI=5; Study Day 14 SDAI=6 | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 14 , Ordinal Scores | Baseline SDAI=6; Study Day 14 SDAI=5 | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 14 , Ordinal Scores | Baseline SDAI=6; Study Day 14 SDAI=6 | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 14 , Ordinal Scores | Baseline SDAI=6; Study Day 14 SDAI=7 | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 14 , Ordinal Scores | Baseline SDAI=7; Study Day 14 SDAI=7 | 1 Participants |
Secondary
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 28 , Ordinal Scores
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
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 28 , Ordinal Scores | Baseline SDAI=5; Study Day 28 SDAI=5 | 4 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 28 , Ordinal Scores | Baseline SDAI=5; Study Day 28 SDAI=6 | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 28 , Ordinal Scores | Baseline SDAI=6; Study Day 28 SDAI=5 | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 28 , Ordinal Scores | Baseline SDAI=6; Study Day 28 SDAI=7 | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 28 , Ordinal Scores | Baseline SDAI=7; Study Day 28 SDAI=7 | 1 Participants |
Secondary
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 42 , Ordinal Scores
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
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 42 , Ordinal Scores | Baseline SDAI=5; Study Day 42 SDAI=5 | 4 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 42 , Ordinal Scores | Baseline SDAI=5; Study Day 42 SDAI=6 | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 42 , Ordinal Scores | Baseline SDAI=6; Study Day 42 SDAI=5 | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 42 , Ordinal Scores | Baseline SDAI=6; Study Day 42 SDAI=6 | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 42 , Ordinal Scores | Baseline SDAI=7; Study Day 42 SDAI=7 | 1 Participants |
Secondary
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 56 , Ordinal Scores
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
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 56 , Ordinal Scores | Baseline SDAI=5; Study Day 56 SDAI=4 | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 56 , Ordinal Scores | Baseline SDAI=5; Study Day 56 SDAI=5 | 3 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 56 , Ordinal Scores | Baseline SDAI=5; Study Day 56 SDAI=6 | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 56 , Ordinal Scores | Baseline SDAI=6; Study Day 56 SDAI=5 | 2 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 56 , Ordinal Scores | Baseline SDAI=6; Study Day 56 SDAI=6 | 1 Participants |
| Dexamethasone Irrigation of Parotid Gland | Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 56 , Ordinal Scores | Baseline SDAI=7; Study Day 56 SDAI=7 | 1 Participants |
Secondary
Summary Statistics of Focus Score
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
Population: 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 | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Summary Statistics of Focus Score | Stage II Screening | 2.5 score on a scale |
| Dexamethasone Irrigation of Parotid Gland | Summary Statistics of Focus Score | Study Day 56 | 1 score on a scale |
| Placebo Irrigation of Parotid Gland | Summary Statistics of Focus Score | Stage II Screening | 1.5 score on a scale |
| Placebo Irrigation of Parotid Gland | Summary Statistics of Focus Score | Study Day 56 | 0.5 score on a scale |
Secondary
Summary Statistics of MRI Scans
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
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Summary Statistics of MRI Scans | Stage II Screening Visit | MRI Abnormal, clinically signficant | 0 Participants |
| Dexamethasone Irrigation of Parotid Gland | Summary Statistics of MRI Scans | Stage II Screening Visit | MRI Normal | 5 Participants |
| Dexamethasone Irrigation of Parotid Gland | Summary Statistics of MRI Scans | Stage II Screening Visit | MRI Abnormal, not clinically signficant | 4 Participants |
| Dexamethasone Irrigation of Parotid Gland | Summary Statistics of MRI Scans | Study Day 56 | MRI Normal | 5 Participants |
| Dexamethasone Irrigation of Parotid Gland | Summary Statistics of MRI Scans | Study Day 56 | MRI Abnormal, not clinically signficant | 3 Participants |
| Dexamethasone Irrigation of Parotid Gland | Summary Statistics of MRI Scans | Study Day 56 | MRI Abnormal, clinically signficant | 1 Participants |
| Placebo Irrigation of Parotid Gland | Summary Statistics of MRI Scans | Study Day 56 | MRI Abnormal, not clinically signficant | 3 Participants |
| Placebo Irrigation of Parotid Gland | Summary Statistics of MRI Scans | Stage II Screening Visit | MRI Abnormal, clinically signficant | 0 Participants |
| Placebo Irrigation of Parotid Gland | Summary Statistics of MRI Scans | Study Day 56 | MRI Normal | 6 Participants |
| Placebo Irrigation of Parotid Gland | Summary Statistics of MRI Scans | Stage II Screening Visit | MRI Normal | 5 Participants |
| Placebo Irrigation of Parotid Gland | Summary Statistics of MRI Scans | Study Day 56 | MRI Abnormal, clinically signficant | 0 Participants |
| Placebo Irrigation of Parotid Gland | Summary Statistics of MRI Scans | Stage II Screening Visit | MRI Abnormal, not clinically signficant | 4 Participants |
Secondary
Summary Statistics of Technetium Scans
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
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dexamethasone Irrigation of Parotid Gland | Summary Statistics of Technetium Scans | Stage II Screening Visit | Normal | 4 Participants |
| Dexamethasone Irrigation of Parotid Gland | Summary Statistics of Technetium Scans | Study Day 56 | Normal | 4 Participants |
| Dexamethasone Irrigation of Parotid Gland | Summary Statistics of Technetium Scans | Stage II Screening Visit | Abnormal | 5 Participants |
| Dexamethasone Irrigation of Parotid Gland | Summary Statistics of Technetium Scans | Study Day 56 | Abnormal | 5 Participants |
| Placebo Irrigation of Parotid Gland | Summary Statistics of Technetium Scans | Stage II Screening Visit | Abnormal | 5 Participants |
| Placebo Irrigation of Parotid Gland | Summary Statistics of Technetium Scans | Stage II Screening Visit | Normal | 4 Participants |
| Placebo Irrigation of Parotid Gland | Summary Statistics of Technetium Scans | Study Day 56 | Abnormal | 4 Participants |
| Placebo Irrigation of Parotid Gland | Summary Statistics of Technetium Scans | Study Day 56 | Normal | 5 Participants |