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
332 participants
INTERVENTIONAL
2011-01-31
2012-01-31
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 2
Ulimorelin Intravenously (IV)
480 microg/kg daily (QD)
experimental 1
Ulimorelin Intravenously (IV)
160 microg/kg daily (QD)
Placebo
Placebo comparator daily (QD)
5% dextrose in water
Placebo
Interventions
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Ulimorelin Intravenously (IV)
480 microg/kg daily (QD)
Ulimorelin Intravenously (IV)
160 microg/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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Fountain Valley Regional Hospital
Fountain Valley, California, United States
Orange Coast Memorial Med. Ctr.
Fountain Valley, California, United States
USC, Colorectal Surgery Division
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Denver VA Medical Center
Denver, Colorado, United States
Nature Coast Clinical Research
Inverness, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Pensacola Research Consultants
Pensacola, Florida, United States
Sunrise Clinical Research, Inc.
Sunrise, Florida, United States
ARS Clinical Trials
Powder Springs, Georgia, United States
So. Illinois Univ. School of Medicine
Springfield, Illinois, United States
Univ. of Louisville, Dept. of Surgery
Louisville, Kentucky, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
CRC of Jackson
Jackson, Mississippi, United States
Creighton Univ. Medical Ctr.
Omaha, Nebraska, United States
Mt. Sinai Hospital
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University Hospitals Case Medical Ctr.
Cleveland, Ohio, United States
Bend Memorial Clinic
Bend, Oregon, United States
Mt. Talbert Medical Offices
Clackamas, Oregon, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
JPS Health Network, Dept. of Surgery
Fort Worth, Texas, United States
Southwest Surgical Associates
Houston, Texas, 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
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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TZP-101-CL-P007
Identifier Type: -
Identifier Source: org_study_id