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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023229-38 | EudraCT Number |
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| Name | Class |
|---|---|
| Norgine | INDUSTRY |
Post-operative administration of ulimorelin is expected to reduce time to recovery of Gastrointestinal (GI) function in patients who have undergone partial large bowel resection
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental 1 | Experimental |
| |
| Experimental 2 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ulimorelin Intravenously (IV) | Drug | 160 µg/kg daily (QD) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery of GI Function | up to 7 days of dosing or until hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Ancillary GI Functions | up to 7 days of dosing or hospital discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glendale Memorial Hospital | Glendale | California | 91204 | United States | ||
| Long Beach Memorial Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23739196 | Derived | Shaw M, Pediconi C, McVey D, Mondou E, Quinn J, Chamblin B, Rousseau F. Safety and efficacy of ulimorelin administered postoperatively to accelerate recovery of gastrointestinal motility following partial bowel resection: results of two randomized, placebo-controlled phase 3 trials. Dis Colon Rectum. 2013 Jul;56(7):888-97. doi: 10.1097/DCR.0b013e31829196d0. |
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| Ulimorelin Invtravenously (IV) |
| Drug |
480 µg/kg daily (QD) |
|
| 5% dextrose in water | Drug | Placebo |
|
| Long Beach |
| California |
| 90806 |
| United States |
| Univ. of Southern California | Los Angeles | California | 90033 | United States |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Palo Alto VA Health Care Ctr | Palo Alto | California | 94304 | United States |
| Citrus Memorial Hospital | Inverness | Florida | 34452 | United States |
| Pensacola Research Consultants | Pensacola | Florida | 32504 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| ARS Clinical Trials | Powder Springs | Georgia | 30127 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| NOLA CVT Surgery | New Orleans | Louisiana | 70115 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| CRC of Jackson | Jackson | Mississippi | 39202 | United States |
| Mount Sinai Hospital | New York | New York | 10021 | United States |
| Sanford Medical Center | Fargo | North Dakota | 58122 | United States |
| Kaiser Permanente Northwest | Clackamas | Oregon | 34452 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Forbes Regional Hospita | Monroeville | Pennsylvania | 15146 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| VA Pittsburgh Health Care System | Pittsburgh | Pennsylvania | 15241 | United States |
| Access Clinical Trials, Inc. | Nashville | Tennessee | 37203 | United States |
| Texas Tech University Health Sciences Center | El Paso | Texas | 79905 | United States |
| Southwest Surgical Associates | Houston | Texas | 77074 | United States |
| VCU Medical Center | Richmond | Virginia | 23219 | United States |
| MultiCare Research Institute | Tacoma | Washington | 98405 | United States |
| UMHAT Emergency Medicine | Sifua | Bulgaria |
| MHAT Tokuda Hospital Sofia | Sofia | Bulgaria |
| Military Medical Academy | Sofia | Bulgaria |
| UMHAT Tzaritza Yoanna ISUL | Sofia | Bulgaria |
| UMHAT St. Marina | Varna | Bulgaria |
| FN Brno | Brno | Czechia |
| St. Anne's University Hospital | Brno | Czechia |
| Hospital Jihlava | Jihlava | Czechia |
| Hospital Liberec | Liberec | Czechia |
| FN Olomouc | Olomouc | Czechia |
| Fakutni Thomayerova nemocnica | Prague | Czechia |
| University Hospital Bulovka | Prague | Czechia |
| CHU Avicenne | Bobigny | France |
| Hopital Beaujon | Clichy Paris | France |
| CHRU Lille | Lille | France |
| CHU Rouen, Hopital Charles Nicolle | Rouen | France |
| Kaunas Clinical Hospital No. 2 | Kaunas | LT-47144 | Lithuania |
| Kaunas Medical University Clinics | Kaunas | LT50009 | Lithuania |
| Republican Klaipeda Hospital | KlaipÄ—da | LT-92231 | Lithuania |
| Klaipeda Hospital | KlaipÄ—da | LT-92288 | Lithuania |
| Institute of Oncology at Vilnius University, Clinic of Surgery | Vilnius | LT-08660 | Lithuania |
| Vilnius City Univ. Hospital Clinic of Surgery | Vilnius | LT-10207 | Lithuania |
| Institute regional de Gastroenterologie si Hepatologie | Cluj-Napoca | Romania |
| Spitalul Clinic Judetean de Urgenta | Oradea | Romania |
| ID | Term |
|---|---|
| D005947 | Glucose |
| D014867 | Water |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
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