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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1127-6202 | Registry Identifier | WHO |
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The purpose of this study is to assess the efficacy and safety of 8 weeks of daily treatment with Ilaprazole (5, 20 and 40 mg), once daily (QD), compared to lansoprazole 30 mg in healing subjects with endoscopically proven erosive esophagitis.
This 8 week study will be conducted by approximately 160 investigators in the United States. During this study, esophagitis healing will be evaluated by endoscopy, heartburn and other symptom relief will be evaluated by questionnaire and study drug levels will be measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ilaprazole 5 mg QD | Experimental |
| |
| Ilaprazole 20 mg QD | Experimental |
| |
| Ilaprazole 40 mg QD | Experimental |
| |
| Lansoprazole 30 mg QD | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ilaprazole | Drug | Ilaprazole 5 mg, capsules, orally, once daily for up to 8 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The crude healing rate of Erosive Esophagitis at week 4 of treatment as assessed by endoscopy. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| The crude healing rate of Erosive Esophagitis at week 8 of treatment as assessed by endoscopy. | Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hueytown | Alabama | United States | ||||
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| Ilaprazole |
| Drug |
Ilaprazole 20 mg, capsules, orally, once daily for up to 8 weeks. |
|
| Ilaprazole | Drug | Ilaprazole 40 mg, capsules, orally, once daily for up to 8 weeks. |
|
| Lansoprazole | Drug | Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks. |
|
| Huntsville |
| Alabama |
| United States |
| Chandler | Arizona | United States |
| Phoenix | Arizona | United States |
| Tempe | Arizona | United States |
| Tucson | Arizona | United States |
| Sherwood | Arkansas | United States |
| Anaheim | California | United States |
| Cypress | California | United States |
| Encinitas | California | United States |
| Garden Grove | California | United States |
| Irvine | California | United States |
| Lancaster | California | United States |
| Mission Hills | California | United States |
| Oakland | California | United States |
| Orange | California | United States |
| Pasadena | California | United States |
| San Diego | California | United States |
| West Covina | California | United States |
| Colorado Springs | Colorado | United States |
| Longmont | Colorado | United States |
| Pueblo | Colorado | United States |
| Bristol | Connecticut | United States |
| Washington D.C. | District of Columbia | United States |
| Longwood | Florida | United States |
| Miami | Florida | United States |
| New Smyrna Beach | Florida | United States |
| Pembroke Pines | Florida | United States |
| Tampa | Florida | United States |
| Zephyrhills | Florida | United States |
| Atlanta | Georgia | United States |
| Conyers | Georgia | United States |
| Newnan | Georgia | United States |
| Tucker | Georgia | United States |
| Boise | Idaho | United States |
| Moline | Illinois | United States |
| Rockford | Illinois | United States |
| Clive | Iowa | United States |
| Davenport | Iowa | United States |
| Dubuque | Iowa | United States |
| Wichita | Kansas | United States |
| Metairie | Louisiana | United States |
| Chevy Chase | Maryland | United States |
| Prince Frederick | Maryland | United States |
| Olive Branch | Mississippi | United States |
| Jefferson City | Missouri | United States |
| Kansas City | Missouri | United States |
| Mexico | Missouri | United States |
| Egg Harbor | New Jersey | United States |
| Albuquerque | New Mexico | United States |
| Binghamton | New York | United States |
| Great Neck | New York | United States |
| Rochester | New York | United States |
| Chapel Hill | North Carolina | United States |
| Fayetteville | North Carolina | United States |
| Greensboro | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Wilmington | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Dayton | Ohio | United States |
| Norman | Oklahoma | United States |
| Oklahoma City | Oklahoma | United States |
| Medford | Oregon | United States |
| Portland | Oregon | United States |
| Beaver Falls | Pennsylvania | United States |
| Harrisburg | Pennsylvania | United States |
| Lansdale | Pennsylvania | United States |
| Warwick | Rhode Island | United States |
| Anderson | South Carolina | United States |
| Charleston | South Carolina | United States |
| Goose Creek | South Carolina | United States |
| Mt. Pleasant | South Carolina | United States |
| Sioux Falls | South Dakota | United States |
| Bristol | Tennessee | United States |
| Chattanooga | Tennessee | United States |
| Johnson City | Tennessee | United States |
| Nashville | Tennessee | United States |
| Amarillo | Texas | United States |
| Austin | Texas | United States |
| Beaumont | Texas | United States |
| Bryan | Texas | United States |
| El Paso | Texas | United States |
| Fort Worth | Texas | United States |
| Houston | Texas | United States |
| Odessa | Texas | United States |
| San Antonio | Texas | United States |
| Midvale | Utah | United States |
| Ogden | Utah | United States |
| Newport News | Virginia | United States |
| Norfolk | Virginia | United States |
| Spokane | Washington | United States |
| Milwaukee | Wisconsin | United States |
| Monroe | Wisconsin | United States |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D006356 | Heartburn |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C119615 | ilaprazole |
| D064747 | Lansoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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