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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 2 | Experimental |
| |
| experimental 1 | Experimental |
| |
| Placebo | Placebo Comparator | Placebo comparator daily (QD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ulimorelin Intravenously (IV) | Drug | 480 microg/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 |
|---|---|---|---|---|---|---|
| Fountain Valley Regional Hospital | Fountain Valley | California | 92708 | United States | ||
| Orange Coast Memorial Med. Ctr. |
| 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 Intravenously (IV) |
| Drug |
160 microg/kg daily (QD) |
|
| 5% dextrose in water | Drug | Placebo |
|
| Fountain Valley |
| California |
| 92708 |
| United States |
| USC, Colorectal Surgery Division | Los Angeles | California | 90033 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Denver VA Medical Center | Denver | Colorado | 80220 | United States |
| Nature Coast Clinical Research | Inverness | Florida | 34452 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Pensacola Research Consultants | Pensacola | Florida | 32504 | United States |
| Sunrise Clinical Research, Inc. | Sunrise | Florida | 33323 | United States |
| ARS Clinical Trials | Powder Springs | Georgia | 30127 | United States |
| So. Illinois Univ. School of Medicine | Springfield | Illinois | 62702 | United States |
| Univ. of Louisville, Dept. of Surgery | Louisville | Kentucky | 40202 | United States |
| UMass Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| CRC of Jackson | Jackson | Mississippi | 39202 | United States |
| Creighton Univ. Medical Ctr. | Omaha | Nebraska | 68121 | United States |
| Mt. Sinai Hospital | New York | New York | 10021 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| University Hospitals Case Medical Ctr. | Cleveland | Ohio | 44106 | United States |
| Bend Memorial Clinic | Bend | Oregon | 97701 | United States |
| Mt. Talbert Medical Offices | Clackamas | Oregon | 97015 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | United States |
| JPS Health Network, Dept. of Surgery | Fort Worth | Texas | 76104 | United States |
| Southwest Surgical Associates | Houston | Texas | 77074 | United States |
| JohnFerenc Del-pesti Hospital | Budapest | Hungary |
| Petz Aladar County Education Hospital | Győr | Hungary |
| County Hospital of Kecskemet | Kecskemét | Hungary |
| St. Gyorgy Hospital of Fejer County | Székesfehérvár | Hungary |
| Fondazione I.R.C.C.S. Policlinico San Matteo | Pavia | Italy |
| Policlinico Universitario Agostino Gemelli -Univ | Rome | Italy |
| IRCCS Policlinico San Donato | San Donato | Italy |
| Plac Hallera, Genl Surgery | Lodz | Poland |
| Univ. Hospital #1, N. Barlicki Med. Univ. | Lodz | Poland |
| Hospital Wolski | Warsaw | Poland |
| Spitalul Clinic de Urgenta "Prof. Dr. Octavian Fodor" | Cluj-Napoca | Romania |
| Spitalul Clinic Judetean de Urgente | Iași | Romania |
| Spitalul Clinic Judetean de Urgenta Oradea | Oradea | Romania |
| Spitalul Clinic Judetean Mures | Târgu Mureş | Romania |
| Spitalul Clinic Judetean de Urgenta Timisoara | Timișoara | Romania |
| Clinical Center of Serbia | Belgrade | Serbia |
| Clinical Hospital Bezanijska Kosa | Belgrade | Serbia |
| Clinical Hospital Center Zvezdara | Belgrade | Serbia |
| Clinical Center Nis | Niš | Serbia |
| Nottingham University Hospital | Nottingham | United Kingdom |
| Scarborough Hospital | Scarborough | United Kingdom |
| Northern General Hospital | Sheffield | United Kingdom |
| 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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