Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether TZP-101 is effective in the management of post operative ileus in subjects undergoing major open abdominal surgery (i.e. partial large bowel resection).
Subjects will be randomized according to an adaptive randomization procedure.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Experimental |
| |
| 5 | Experimental |
| |
| 6 | Experimental |
| |
| 7 | Experimental |
| |
| 8 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5% dextrose in water | Drug | 60 ml IV infusion over 30 minutes |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to recovery of gastrointestinal function as defined by the time to first bowel movement. | 7 days of dosing plus 7 days after administration of last dose |
| Measure | Description | Time Frame |
|---|---|---|
| time to tolerance of first solid food | 7 days post administration of last dose |
Not provided
Inclusion Criteria:
Subjects who meet all of the following inclusion criteria may be enrolled in the study:
Exclusion Criteria:
Subjects who meet any of the following exclusion criteria may not be enrolled in the study:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Office of Dr. Phillip Fleshner | Los Angeles | California | 90048 | United States | ||
| University of Miami Clinic |
Not provided
Not provided
Not provided
Not provided
Not provided
| TZP-101 | Drug | 20 micrograms/kg IV 2ml/minute for 30 minutes |
|
| TZP-101 | Drug | 40 micrograms/kg IV 2 ml/minute for 30 minutes |
|
| TZP-101 | Drug | 80 micrograms/kg IV 2ml/minute for 30 minutes |
|
| TZP-101 | Drug | 160 micrograms/kg IV 2ml/minute over 30 minutes |
|
| TZP-101 | Drug | 320 micrograms/kg IV 2ml/minute for 30 minutes |
|
| TZP-101 | Drug | 480 micrograms/kg IV 2ml/minute over 30 minutes |
|
| TZP-101 | Drug | 600 micrograms/kg IV 2ml/minute for 30 minutes |
|
| Miami |
| Florida |
| 33136 |
| United States |
| Renstar Medical Research | Ocala | Florida | 34471 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Univ. of Maryland, R.A. Cowley Shock Trauma Center | Baltimore | Maryland | 21201 | United States |
| Baystate Medical Center/Baystate Health | Springfield | Massachusetts | 01199 | United States |
| Michigan State/Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
| Stony Brook University Hospital | Stony Brook | New York | 11794 | United States |
| Mid Dakota Clinic, PC | Bismarck | North Dakota | 58501 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| St. John's Hospital | Bangalore | Karnataka | India |
| Stanley Medical College | Chennai | 600001 | India |
| Asian Institute of Gastroenterology | Hyderabad | 500082 | India |
| Nizams Institute of Medical Science | Hyderabad | 500083 | India |
| Mediciti Hospitals | Hyderabad | 50063 | India |
| Amrita Institute of Medical Sciences | Kochi | 682026 | India |
| Lakeshore Hospital | Kochi | 682304 | India |
| Sanjay Gandhi Post-Graduate Institute of Medical Sciences | Lucknow | 226014 | India |
| Clinica de Chirugie General IV, Spitalul Universitar | Bucharest | 00000 RO | Romania |
| Clinica de Chirugie Generala I, Spitalul Universitar | Bucharest | 00000 RO | Romania |
| Clinica de Chirugie Generala III, Spitalul Universitar | Bucharest | 00000 RO | Romania |
| Institul Clinic Fundeni | Bucharest | 00000 RO | Romania |
| Spitalul Clinic Colentina | Bucharest | 00000 RO | Romania |
| Spitalul Clinic Coltea | Bucharest | 00000 RO | Romania |
| Spitalul Clinic de Urgenta Floreasca | Bucharest | 00000 RO | Romania |
| Spitalul Urg. SF. Pantelimon | Bucharest | 021659 RO | Romania |
| Spitalul Universitar Elias | Bucharest | Romania |
| ID | Term |
|---|---|
| D005947 | Glucose |
| D014867 | Water |
| C528884 | ulimorelin |
| 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 |
Not provided
Not provided