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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-005105-18 |
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The purpose of this study is to evaluate the effect of ADX10059 in patients with gastroesophageal reflux disease who are partial responders to proton pump inhibitors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADX10059 50 mg | Experimental | twice-daily |
|
| ADX10059 100 mg | Experimental | twice-daily |
|
| ADX10059 150 mg | Experimental | twice-daily |
|
| ADX10059 Matching Placebo | Placebo Comparator | twice-daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADX10059 | Drug | oral administration |
| |
| ADX10059 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of GERD symptom free days in week 4 of study medication treatment | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| GERD symptoms | 4 weeks | |
| Sleep disturbance | 4 weeks | |
| Use of antacid medications |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arizona | United States | ||||
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| Drug |
oral administration |
|
| ADX10059 | Drug | oral administration |
|
| ADX10059 Matching Placebo | Drug | oral administration |
|
| 4 weeks |
| Global assessment of GERD | 4 weeks |
| Safety and tolerability assessments | 4 weeks |
| Tucson |
| Arizona |
| United States |
| Anaheim | California | United States |
| San Diego | California | United States |
| Colorado Springs | Colorado | United States |
| Jacksonville | Florida | United States |
| Port Orange | Florida | United States |
| Moline | Illinois | United States |
| 54 | Kansas City | Kansas | United States |
| 62 | Kansas City | Kansas | United States |
| Jackson | Mississippi | United States |
| Setauket | New York | United States |
| Harrisburg | North Carolina | United States |
| High Point | North Carolina | United States |
| Huntersville | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Fargo | North Dakota | United States |
| Cleveland | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Philadelphia | Pennsylvania | United States |
| Charleston | South Carolina | United States |
| Germantown | Tennessee | United States |
| 71 | Nashville | Tennessee | United States |
| 73 | Nashville | Tennessee | United States |
| Baytown | Texas | United States |
| Houston | Texas | United States |
| Waukesha | Wisconsin | United States |
| Bordeaux | France |
| Colombes | France |
| Lyon | France |
| Nantes | France |
| Nice | France |
| Rouen | France |
| Dresden | Germany |
| Garmisch-Partenkirchen | Germany |
| Magdeburg | Germany |
| Munich | Germany |
| Amsterdam | Netherlands |
| Sankt Gallen | Switzerland |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D006356 | Heartburn |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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