Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
330 participants
INTERVENTIONAL
2011-02-28
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Experimental 1
Ulimorelin Intravenously (IV)
160 µg/kg daily (QD)
Experimental 2
Ulimorelin Invtravenously (IV)
480 µg/kg daily (QD)
Placebo
5% dextrose in water
Placebo
Interventions
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Ulimorelin Intravenously (IV)
160 µg/kg daily (QD)
Ulimorelin Invtravenously (IV)
480 µg/kg daily (QD)
5% dextrose in water
Placebo
Eligibility Criteria
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Inclusion Criteria
* Scheduled to undergo open bowel resection with colonic anastomosis
* For women who can potentially become pregnant a pregnancy test at screening and admission must be negative
Exclusion Criteria
* Pregnant or breastfeeding
* Known history of drug or alcohol abuse within the previous year
18 Years
80 Years
ALL
No
Sponsors
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Norgine
INDUSTRY
Tranzyme, Inc.
INDUSTRY
Responsible Party
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Locations
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Glendale Memorial Hospital
Glendale, California, United States
Long Beach Memorial Medical Center
Long Beach, California, United States
Univ. of Southern California
Los Angeles, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Palo Alto VA Health Care Ctr
Palo Alto, California, United States
Citrus Memorial Hospital
Inverness, Florida, United States
Pensacola Research Consultants
Pensacola, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
ARS Clinical Trials
Powder Springs, Georgia, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
NOLA CVT Surgery
New Orleans, Louisiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
CRC of Jackson
Jackson, Mississippi, United States
Mount Sinai Hospital
New York, New York, United States
Sanford Medical Center
Fargo, North Dakota, United States
Kaiser Permanente Northwest
Clackamas, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Forbes Regional Hospita
Monroeville, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, United States
Access Clinical Trials, Inc.
Nashville, Tennessee, United States
Texas Tech University Health Sciences Center
El Paso, Texas, United States
Southwest Surgical Associates
Houston, Texas, United States
VCU Medical Center
Richmond, Virginia, United States
MultiCare Research Institute
Tacoma, Washington, 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, , Lithuania
Kaunas Medical University Clinics
Kaunas, , Lithuania
Republican Klaipeda Hospital
Klaipėda, , Lithuania
Klaipeda Hospital
Klaipėda, , Lithuania
Institute of Oncology at Vilnius University, Clinic of Surgery
Vilnius, , Lithuania
Vilnius City Univ. Hospital Clinic of Surgery
Vilnius, , Lithuania
Institute regional de Gastroenterologie si Hepatologie
Cluj-Napoca, , Romania
Spitalul Clinic Judetean de Urgenta
Oradea, , Romania
Countries
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References
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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.
Other Identifiers
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2010-023229-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TZP-101-CL-P008
Identifier Type: -
Identifier Source: org_study_id