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| ID | Type | Description | Link |
|---|---|---|---|
| 11-D-0094 | Other Identifier | CNS IRB number |
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Slow enrollment
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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:
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:
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:
Exploratory endpoints
- Changes in mechanistic endpoints from baseline to study Days 14, 28, 42, and 56.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Parotid Irrigation | Placebo Comparator | Within-Subject, Double-Blind, Placebo-Controlled Study. This parotid gland is irrigated with saline (placebo). { UPDATE: drug(generic) was administered at what time pt, dose of drug, route administration, frequency} |
|
| Dexamethasone Parotid Irrigation | Experimental | Within-Subject, Double-Blind, Placebo-Controlled Study. This parotid gland is irrigated with dexamethasone {UPDATE: drug (generic) was administered at what time pt, dose of drug, route administration, frequency} |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone Parotid Irrigation | Drug | Irrigation of the parotid gland from one side of the mouth with dexamethasone. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Study Day 0) to Study Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Ilias G Alevizos, D.M.D. | National Institute of Dental and Craniofacial Research (NIDCR) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9797551 | Background | Izumi M, Eguchi K, Nakamura H, Takagi Y, Kawabe Y, Nakamura T. Corticosteroid irrigation of parotid gland for treatment of xerostomia in patients with Sjogren's syndrome. Ann Rheum Dis. 1998 Aug;57(8):464-9. doi: 10.1136/ard.57.8.464. | |
| 19004065 | Background | Takagi Y, Katayama I, Tashiro S, Nakamura T. Parotid irrigation and cevimeline gargle for treatment of xerostomia in Sjogren's syndrome. J Rheumatol. 2008 Nov;35(11):2289-91. doi: 10.3899/jrheum.080370. No abstract available. |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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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.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | Dexamethasone Irrigation of Parotid Gland | Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28. |
| FG001 | Placebo Irrigation of Parotid Gland | Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Safety Population: all enrolled participants that received any parotid saline irrigation used to determine parotid filling volume during Stage I screening.
| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Safety Population: all enrolled participants that received any parotid saline irrigation used to determine parotid filling volume during Stage I screening. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Mean | Standard Error | g/min | Baseline (Study Day 0) to Study Day 56 |
|
Treatment emergent adverse events (AEs) are being reported in this document. Reporting period was 71 days from Randomization (Study Day 0) through Safety Follow-up (71 days).
Adverse events were graded according to a descriptive scale based on the NIAID Division of Acquired Immunodeficiency Syndrome Table for Grading the Severity of Adverse Events. Adverse events were summarized by parotid treatment when related to the side of the mouth of parotid irrigation; otherwise, adverse events were summarized as not related to side of the mouth.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexamethasone Irrigation | Adverse event from the side of the mouth that received the parotid dexamethasone irrigation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ilias Alevizos | NIDCR/NIH | 3014966207 | alevizosi@mail.nih.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 1, 2015 | Apr 10, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 9, 2018 | Apr 10, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012859 | Sjogren's Syndrome |
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Placebo Parotid Irrigation | Drug | Irrigation of the parotid gland on the opposite side of the mouth with placebo saline. |
|
| Baseline to 14 days post-baseline |
| 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. | Baseline to 28 days post-baseline |
| 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. | Baseline to 42 days post-baseline |
| 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. | Baseline (Study Day 0) through Study Day 56 |
| 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. | Baseline (Study Day 0) through Study Day 56 |
| 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. | Baseline (Study Day 0) through Study Day 56 |
| Patient Dry Mouth Questionnaire: Have You Experienced Any Changes in Your Sense of Taste Since Starting the Study? | 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. | Baseline (Study Day 0) through Study Day 56 |
| Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: | The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. | Baseline (Study Day 0) through Study Day 56 |
| Patient Dry Mouth Questionnaire: Do You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study? | 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. | Baseline (Study Day 0) through Study Day 56 |
| Patient Dry Mouth Questionnaire: If You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study, Specify: | The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. | Baseline (Study Day 0) through Study Day 56 |
| 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. | Baseline (Study Day 0) through Study Day 56 |
| 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. | Baseline (Study Day 0) through Study Day 56 |
| Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? | 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. | Baseline (Study Day 0) through Study Day 56 |
| Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? | 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. | Baseline (Study Day 0) through Study Day 56 |
| Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: | 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. | Baseline (Study Day 0) through Study Day 56 |
| Patient Dry Mouth Questionnaire: Do You Have More Difficulty Swallowing Dry Foods Without Additional Liquids Since Starting the Study? | 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. | Baseline (Study Day 0) through Study Day 56 |
| 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 | Baseline (Study Day 0) through Study Day 56 |
| 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. | Baseline (Study Day 0) through Study Day 56 |
| 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. | Baseline (Study Day 0) through Study Day 56 |
| 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 | Baseline (Study Day 0) through Study Day 56 |
| 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. | Baseline (Study Day 0) through Study Day 56 |
| 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. | Baseline (Study Day 0) through Study Day 56 |
| 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 | Baseline (Study Day 0) through Study Day 56 |
| 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 | Baseline (Study Day 0) through Study Day 56 |
| Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Ordinal Numeric Scale) | Ordinal Scale 0:least to 10:greatest level of disease activity | Baseline (Study Day 0) through Study Day 56 |
| Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) | Nominal scale values: Inactive; Low; Moderate; High | Baseline (Study Day 0) through Study Day 56 |
| Sjögren's Disease Activity Index: Do You Consider Your Patient in a Satisfactory State of 'Minimal Disease Activity'? | Response: Yes or No | Baseline (Study Day 0) through Study Day 56 |
| 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. | Baseline (Study Day 0) through Study Day 56 |
| 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 | Baseline (Study Day 0) through Study Day 56 |
| Sjögren's Disease Activity Index: Compared With Baseline, do You Consider Your Patient Presents a Systemic Flare of the Participant's pSS (Primary Sjögren's Syndrome): | Response: Yes; No | Baseline (Study Day 0) through Study Day 56 |
| Sjögren's Disease Activity Index Shift Table. Question: Do You Consider Your Patient in a Satisfactory State of "Minimal Disease Activity? The Shift Table Data Was Not Rich Enough to Perform McNemar's Test on the Shift Tables of Any of the Study Days. | Possible Response: Yes or No | Baseline (Study Day 0) through Study Day 56 |
| Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 14 , Ordinal Scores | 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. | Baseline (Study Day 0) through Study Day 14 |
| 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. | Baseline (Study Day 0) through Study Day 28 |
| 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. | Baseline (Study Day 0) through Study Day 42 |
| 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. | Baseline (Study Day 0) through Study Day 56 |
| Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale | Possible response on nominal scale: Inactive; Low; Moderate; High SDAI. | Baseline (Study Day 0) to Study Day 56 |
| Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 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. | Baseline (Study Day 0) to Study Day 14 |
| 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. | Baseline (Study Day 0) to Study Day 28 |
| 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. | Baseline (Study Day 0) to Study Day 42 |
| 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. | Baseline (Study Day 0) to Study Day 56 |
| Summary Statistics of MRI Scans | Medical evaluations of MRI Scans. Possible evaluations include: i) Normal; ii) Abnormal, not clinically significant; iii) Abnormal, clinically significant. | Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56 |
| Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit | 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). | Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56 |
| Summary Statistics of Technetium Scans | Medical evaluations of Technetium Scans. Possible evaluations include: i) Normal; and ii) Abnormal. | Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56 |
| Shift Table of the Change in Parotid Technetium Scan at Study Day 56 From Stage II Screening Visit | 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. | Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56 |
| 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). | Stage II screening (within 6 wks before baseline) through 56 days post-baseline |
| 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. | Stage II Screening (within 6 wks before baseline) through 56 days post-baseline |
| 1754137 | Background | Manor W. A clinical learning experience in discharge planning. Nurse Educ. 1991 Nov-Dec;16(6):35. No abstract available. |
| parotid glands |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants | Participants |
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| Waist Circumference | On January 9, 2013, the field for waist circumference was removed as a required field in the database collection forms. As of that date, only 2 participants had records for waist circumference entered into the database. | Mean | Full Range | cm | Participants |
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| Weight | On January 9, 2013, the field for weight was removed as a required field in the database collection forms. As of that date, only 6 participants had records for weight entered into the database. | Mean | Full Range | kg | Participants |
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| Height | On January 9, 2013, the field for height was removed as a required field in the database collection forms. As of that date, only 6 participants had had records for height entered into the database. | Mean | Full Range | cm | Participants |
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| Parotid Fill Volume | Fill volumes were determined by injecting saline using a syringe into the parotid. Injection was terminated when the parotid volume was full or a maximum of 1 mL was injected. | Two participants in the Safety population were never randomized. These two participants were thus entered in the table as "not randomized" | Median | Full Range | mL/min | parotid glands |
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| Saliva Flow | Two participants in the safety population were not randomized and thus their saliva flow was not recorded at their baseline randomization visit. | Mean | Standard Deviation | mL/min | parotid glands |
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| 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). | The biopsy to determine the Focus score was only performed on the right-side parotid, thus only half the parotids have focus scores at baseline (4 dexamethasone randomized parotids; 4 placebo randomized parotids). Three parotids (participants) did not have biopsies at baseline (Stage I Screening). | Median | Full Range | score on a scale | parotid glands |
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| MRI Scan Evaluation | Baseline table counts are the count of parotid glands (2 per participant). In the table: "Abnormal, not clinically significant" is abbreviated as "Abnormal ncs"; "Abnormal, clinically significant" is abbreviated as "Abnormal cs". | Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized" | Count of Units | parotid glands | parotid glands |
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| Technetium Scan Evaluation | Baseline table counts are the count of parotid glands (2 per participant) | Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized" | Count of Units | parotid glands | parotid glands |
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| Technetium Isotope Uptake | Baseline table counts are the count of parotid glands (2 per participant). | Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized" | Count of Units | parotid glands | parotid glands |
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| Technetium Release with Stimulation | Baseline table counts are the count of parotid glands (2 per participant). | Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized" | Count of Units | parotid glands | parotid glands |
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Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on Study Day 0 and Study Day 28. |
| OG001 | Placebo Irrigation of Parotid Gland | Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28. |
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| 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. | 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. | Posted | Mean | Standard Error | g/min | Baseline to 14 days post-baseline | Parotid gland from one side of the mouth | Parotid gland from one side of the mouth |
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| 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. | 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. | Posted | Mean | Standard Error | g/min | Baseline to 28 days post-baseline | Parotid gland on one side of the mouth | Parotid gland on one side of the mouth |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | g/min | Baseline to 42 days post-baseline | Parotid galnd on one side of the mouth | Parotid galnd on one side of the mouth |
|
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) through Study Day 56 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) through Study Day 56 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) through Study Day 56 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) through Study Day 56 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) through Study Day 56 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) through Study Day 56 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) through Study Day 56 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) through Study Day 56 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) through Study Day 56 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) through Study Day 56 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) through Study Day 56 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) through Study Day 56 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) through Study Day 56 |
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) through Study Day 56 |
|
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) through Study Day 56 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) through Study Day 56 |
|
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) through Study Day 56 |
|
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) through Study Day 56 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) through Study Day 56 |
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) through Study Day 56 |
|
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) through Study Day 56 |
|
|
|
|
| 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 | 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. | Posted | Median | Full Range | units on a scale | Baseline (Study Day 0) through Study Day 56 |
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) through Study Day 56 |
|
|
|
| Secondary | Sjögren's Disease Activity Index: Do You Consider Your Patient in a Satisfactory State of 'Minimal Disease Activity'? | Response: Yes or No | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) through Study Day 56 |
|
|
|
| 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. | 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. | Posted | Median | Full Range | score on a scale | Baseline (Study Day 0) through Study Day 56 |
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) through Study Day 56 |
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) through Study Day 56 |
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) through Study Day 56 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) through Study Day 14 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) through Study Day 28 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) through Study Day 42 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) through Study Day 56 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) to Study Day 56 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) to Study Day 14 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) to Study Day 28 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) to Study Day 42 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline (Study Day 0) to Study Day 56 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56 |
|
|
|
| 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). | 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. | Posted | Count of Participants | Participants | Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56 |
|
|
|
| Secondary | Summary Statistics of Technetium Scans | Medical evaluations of Technetium Scans. Possible evaluations include: i) Normal; and ii) Abnormal. | 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. | Posted | Count of Participants | Participants | Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56 |
|
|
|
| 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). | 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. | Posted | Median | Full Range | score on a scale | Stage II screening (within 6 wks before baseline) through 56 days post-baseline | Parotid gland on right side of mouth | Parotid gland on right side of mouth |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Stage II Screening (within 6 wks before baseline) through 56 days post-baseline |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 2 |
| 9 |
| EG001 | Placebo Irrigation | Adverse event from the side of the mouth that received the parotid placebo irrigation | 0 | 9 | 0 | 9 | 2 | 9 |
| EG002 | Side of Mouth Not Applicable | Side of mouth is not applicable to the adverse event | 0 | 9 | 0 | 9 | 5 | 9 |
| Parotid gland enlargement | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 14.0 | Systematic Assessment | Elevated liver enzymes (ALT, AST) |
|
| Aphonia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 14.0 | Systematic Assessment | Migraine Headache |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment | Vertigo |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment | Ecchymosis right side of face |
|
Not provided
Not provided
Not provided
| D012216 |
| Rheumatic Diseases |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Abnormal cs |
|
| Not done |
|
| Abnormal cs |
|
| Not done |
|
| Abnormal cs |
|
| Not done |
|
| Not done |
|
| Not done |
|
| Not done |
|
| Not done |
|
| Not done |
|
| Not done |
|
| Not done |
|
| Not done |
|
| Not done |
|
| No |
|
| Study Day 28 |
|
| Study Day 42 |
|
| Study Day 56 |
|
| Weakness |
|
| Too few Teeth |
|
| Other |
|
| Study Day 14 |
|
|
| Study Day 28 |
|
|
| Study Day 42 |
|
|
| Study Day 56 |
|
|
| No |
|
| Study Day 28 |
|
| Study Day 42 |
|
| Study Day 56 |
|
| No |
|
| Study Day 28 |
|
| Study Day 42 |
|
| Study Day 56 |
|
| Foods taste more intense (for example, more sweet) |
|
| I have persistent bad taste in my mouth |
|
| Study Day 14 |
|
|
| Study Day 28 |
|
|
| Study Day 42 |
|
|
| Study Day 56 |
|
|
| No |
|
| Study Day 28 |
|
| Study Day 42 |
|
| Study Day 56 |
|
| I have gum pain |
|
| I have pain in my jaws or TMJ |
|
| Study Day 14 |
|
|
| Study Day 28 |
|
|
| Study Day 42 |
|
|
| Study Day 56 |
|
|
| No |
|
| Study Day 28 |
|
| Study Day 42 |
|
| Study Day 56 |
|
| Title | Measurements |
|---|---|
|
| Baseline: Chew sugared gum or mints |
|
| Baseline: Chew sugarless gum or mints |
|
| Study Day 14: Sip water |
|
| Study Day 14: Sip liquids other than water |
|
| Study Day 14: use commercial products |
|
| Study Day 14: Chew sugared gum or mints |
|
| Study Day 14: Chew sugarless gum or mints |
|
| Study Day 28: Sip water |
|
| Study Day 28: Sip liquids other than water |
|
| Study Day 28: use commercial products |
|
| Study Day 28: Chew sugared gum or mints |
|
| Study Day 28: Chew sugarless gum or mints |
|
| Study Day 42: Sip water |
|
| Study Day 42: Sip liquids other than water |
|
| Study Day 42: use commercial products |
|
| Study Day 42: Chew sugared gum or mints |
|
| Study Day 42: Chew sugarless gum or mints |
|
| Study Day 56: Sip water |
|
| Study Day 56: Sip liquids other than water |
|
| Study Day 56: use commercial products |
|
| Study Day 56: Chew sugared gum or mints |
|
| Study Day 56: Chew sugarless gum or mints |
|
| Study Day 14 |
|
| Study Day 28 |
|
| Study Day 42 |
|
| Study Day 56 |
|
| Study Day 14 |
|
| Study Day 28 |
|
| Study Day 42 |
|
| Study Day 56 |
|
| Study Day 14 |
|
| Study Day 28 |
|
| Study Day 42 |
|
| Study Day 56 |
|
| No |
|
| Study Day 28 |
|
| Study Day 42 |
|
| Study Day 56 |
|
| Screening II: No; Study Day: No |
|
| Study Day 28 |
|
| Study Day 42 |
|
| Study Day 56 |
|
|
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. |
| McNemar |
| 1.000 |
| Other |
| 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. | McNemar | 0.500 | Other |
| 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. | McNemar | 1.000 | Other |
| Screening II: No; Study Day: No |
|
| Study Day 28 |
|
| Study Day 42 |
|
| Study Day 56 |
|
| Screening II: No; Study Day: No |
|
| Study Day 28 |
|
| Study Day 42 |
|
| Study Day 56 |
|
|
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. |
| McNemar |
| 1.000 |
| Other |
| Screening II: No; Study Day: No |
|
| Study Day 28 |
|
| Study Day 42 |
|
| Study Day 56 |
|
|
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. |
| McNemar |
| 1.000 |
| Other |
| 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. | McNemar | 1.000 | Other |
| 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. | McNemar | 1.000 | Other |
| Screening II: No; Study Day: No |
|
| Study Day 28 |
|
| Study Day 42 |
|
| Study Day 56 |
|
| Screening II: No; Study Day: Yes |
|
| Screening II: No; Study Day: No |
|
| Study Day 28 |
|
|
| Study Day 42 |
|
|
| Study Day 56 |
|
|
| Screening II: No; Study Day: Yes |
|
| Screening II: No; Study Day: No |
|
| Study Day 28 |
|
|
| Study Day 42 |
|
|
| Study Day 56 |
|
|
|
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. |
| McNemar |
| 1.000 |
| Other |
| 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. | McNemar | 1.000 | Other |
| 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. | McNemar | 1.000 | Other |
| Screening II: No; Study Day: No |
|
| Study Day 28 |
|
| Study Day 42 |
|
| Study Day 56 |
|
|
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. |
| McNemar |
| 0.625 |
| Other |
| 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. | McNemar | 0.5000 | Other |
| 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. | McNemar | 1.000 | Other |
| Title | Measurements |
|---|---|
|
| Study Day 42 |
|
| Study Day 56 |
|
| High |
|
| Study Day 14 |
|
| Study Day 28 |
|
| Study Day 42 |
|
| Study Day 56 |
|
| No |
|
| Study Day 28 |
|
| Study Day 42 |
|
| Study Day 56 |
|
| Title | Measurements |
|---|---|
|
| Study Day 42 |
|
| Study Day 56 |
|
| Worse |
|
| Much worse |
|
| Study Day 14 |
|
| Study Day 28 |
|
| Study Day 42 |
|
| Study Day 56 |
|
| No |
|
| Study Day 28 |
|
| Study Day 42 |
|
| Study Day 56 |
|
| No |
|
| Study Day 42 |
|
| Study Day 56 |
|
| Baseline SDAI=6; Study Day 14 SDAI=6 |
|
| Baseline SDAI=6; Study Day 14 SDAI=7 |
|
| Baseline SDAI=7; Study Day 14 SDAI=7 |
|
| Baseline SDAI=6; Study Day 28 SDAI=7 |
|
| Baseline SDAI=7; Study Day 28 SDAI=7 |
|
| Baseline SDAI=6; Study Day 42 SDAI=6 |
|
| Baseline SDAI=7; Study Day 42 SDAI=7 |
|
| Baseline SDAI=6; Study Day 56 SDAI=5 |
|
| Baseline SDAI=6; Study Day 56 SDAI=6 |
|
| Baseline SDAI=7; Study Day 56 SDAI=7 |
|
| Baseline Inactive to Study Day High |
|
| Baseline Low to Study Day Inactive |
|
| Baseline Low to Study Day Low |
|
| Baseline Low to Study Day Moderate |
|
| Baseline Low to Study Day High |
|
| Baseline Moderate to Study Day Inactive |
|
| Baseline Moderate to Study Day Low |
|
| Baseline Moderate to Study Day Moderate |
|
| Baseline Moderate to Study Day High |
|
| Baseline High to Study Day Inactive |
|
| Baseline High to Study Day Low |
|
| Baseline High to Study Day Moderate |
|
| Baseline High to Study Day High |
|
| Study Day 28 |
|
| Study Day 42 |
|
| Study Day 56 |
|
| Baseline SDAI=6; Study Day 14 SDAI=7 |
|
| Baseline SDAI=7; Study Day 14 SDAI=7 |
|
| Baseline SDAI=6; Study Day 28 SDAI=7 |
|
| Baseline SDAI=7; Study Day 28 SDAI=7 |
|
| Baseline SDAI=7; Study Day 42 SDAI=7 |
|
| Baseline SDAI=7; Study Day 56 SDAI=7 |
|
| MRI Abnormal, clinically signficant |
|
| Study Day 56 |
|
| Screening Normal; Study Day 56 Abnormal cs |
|
| Screening Abnormal ncs; Study Day 56 Normal |
|
| Screening Abnormal ncs; Study Day 56 Abnormal ncs |
|
| Screening Abnormal ncs; Study Day 56 Abnormal cs |
|
| Screening Abnormal cs; Study Day 56 Normal |
|
| Screening Abnormal cs; Study Day 56 Abnormal ncs |
|
| Screening Abnormal cs; Study Day 56 Abnormal cs |
|
| Study Day 56 |
|
| Baseline Abnormal; Study Day 56 Normal |
|
| Baseline Abnormal; Study Day 56 Abnormal |
|
|
| Study Day 56 |
|
|
| Screening Focus=2; Day 56 Focus=0 |
|
| Screening Focus=2; Day 56 Focus=5 |
|
| Screening Focus=3; Day 56 Focus=not done |
|
| Screening Focus=12; Day 56 Focus=3 |
|
| Screening Focus=not done; Day 56 Focus=not done |
|