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CJ-023,423 is a new medication being developed as an anti-inflammatory agent for the treatment of the signs and symptoms of osteoarthritis (OA). The purpose of this study is to evaluate whether patients treated with CJ-023,423 for 7 days (14 doses) have fewer gastrointestinal ulcers compared to patients treated with naproxen and placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 | Placebo Comparator |
| |
| 1 | Experimental | 75 mg BID |
|
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CJ-023,423 | Drug | 75 mg BID |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is the presence of gastroduodenal ulcers in each subject, as determined by a UGI endoscopy at the end of the treatment | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent, all-causality GI body system adverse events | Duration of trial | |
| Severity of Dyspepsia Assessment (SODA) | Duration of trial | |
| Post treatment gastric, duodenal and gastroduodenal endoscopic scores (according to the mucosal grading scale). The gastroduodenal score is defined as the higher of the gastric and duodenal scores. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Anaheim | California | 92801 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C522837 | grapiprant |
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Drug |
placebo |
|
| naproxen | Drug | naproxen |
|
| Duration of trial |
| Incidence of any gastric ulcer | Duration of trial |
| Incidence of any duodenal ulcer | Duration of trial |
| Incidence of any gastroduodenal erosion or ulcer | Duration of trial |
| Incidence of any gastric erosion or ulcer | Duration of trial |
| Incidence of any duodenal erosion or ulcer | Duration of trial |
| Incidence of any esophageal ulcer using the traditional grading method of: normal, erosion or ulcer | Duration of trial |
| Incidence of any esophageal ulcer or erosion using the LA classification: esophageal ulcers and erosions method with a Grade A, B, C, or D) | Duration of trial |
| Number of gastroduodenal ulcers in each subject | Duration of trial |
| San Diego |
| California |
| 92103-6204 |
| United States |
| Pfizer Investigational Site | Jupiter | Florida | 33458 | United States |
| Pfizer Investigational Site | Ocoee | Florida | 34761 | United States |
| Pfizer Investigational Site | South Miami | Florida | 33143 | United States |
| Pfizer Investigational Site | New York | New York | 10021 | United States |
| Pfizer Investigational Site | Raleigh | North Carolina | 27607 | United States |
| Pfizer Investigational Site | Raleigh | North Carolina | 27612 | United States |
| Pfizer Investigational Site | Houston | Texas | 77074 | United States |
| Pfizer Investigational Site | Houston | Texas | 77090 | United States |
| Pfizer Investigational Site | Chesapeake | Virginia | 23320 | United States |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |