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The primary objective of this clinical study is to determine the impact of P-552 oral rinse on salivary volume after administration of a single dose of P-552and versus vehicle rinse. Changes in oral mucosal wetness will be assessed via collection of salivary output and via measurement of oral wetness using the Periotron 8000 instrument.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P-552 on Day 1 and Placebo on Day 2 | Experimental | Randomly assigned subjects will receive a single dose of P-552 on Day 1 followed by a single dose of Placebo on Day 2 |
|
| Placebo on Day 1 and P-552 on Day 2 | Experimental | Randomly assigned subjects will receive a single dose of Placebo on Day 1 followed by a single dose of P-52 on Day 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P-552 | Drug | P-552 will be administered as 10 mL mouth rinse to be swished in the mouth fro 30 seconds and then completely expectorated. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Salivary volume | 60 minutes | |
| Salivary Volume | 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Periotron measurement | measurement of mucosal wetness | 15, 30 and 90 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts University School of Dental Medicine | Boston | Massachusetts | 02111 | United States |
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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 |
|---|---|
| D014867 | Water |
| D007267 | Injections |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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|
| Placebo | Drug | Placebo will be administered as 10 mL mouth rinse to be swished in the mouth for 30 seconds and then completely expectorated. |
|
|
| 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 |
| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |