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The purpose of this study is to evaluate the effectiveness of NGX267 in the improvement of decreased salivary flow associated with primary or secondary Sjögren's syndrome.
For each patient, the study includes four periods of treatment separated by a washout period that may range from 4 - 8 days according to patient and site discretion. Each treatment period includes two overnight stays in the clinic. One dose of study drug is taken during each treatment period
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo capsules |
|
| 2 | Experimental | 2 capsules in the am of each treatment period |
|
| 3 | Experimental | 2 capsules in the am of each treatment period |
|
| 4 | Experimental | 2 capsules in am of each treatment period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NGX267 | Drug | 2 capsules in the am of each treatment period |
| |
| NGX267 |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative and qualitative assessment of dry mouth | 36 days |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability and safety of NGX267 | 36 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Walter F. Chase, M.D. | Walter F. Chase MD. PA | Principal Investigator |
| Alan Kivitz, M.D. | Altoona Center for Clinical Research | Principal Investigator |
| Frederick B. Vivino, M.D. | Penn Rheumatology Associates and Sjogren's Syndrome Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States | ||
| Penn Rheumatology Associates and Sjogren's Syndrome Center |
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| ID | Term |
|---|---|
| D014987 | Xerostomia |
| D012859 | Sjogren's Syndrome |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D001172 | Arthritis, Rheumatoid |
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| ID | Term |
|---|---|
| C470586 | (S)-2-ethyl-8-methyl-1-thia-4,8-diazaspiro(4.5)decan-3-one |
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| Drug |
2 capsules in the am of each treatment period |
|
| NGX267 | Drug | 2 capsules in the am of each treatment period |
|
| NGX267 | Drug | 2 capsules in the am of each treatment period |
|
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Walter F. Chase MD PA | Austin | Texas | 78705 | United States |
| D001168 |
| Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic 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 |