Ulimorelin Study of Efficacy and Safety (ULISES 007)
ULISES
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intravenous (IV) Ulimorelin Administered Post-Operatively to Accelerate Recovery of Gastrointestinal (GI) Motility in Subjects Who Have Undergone Partial Bowel Resection
1 other identifier
interventional
332
7 countries
45
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2011
Shorter than P25 for phase_3
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 26, 2011
CompletedFirst Posted
Study publicly available on registry
January 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedJuly 26, 2012
July 1, 2012
1 year
January 26, 2011
July 25, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Recovery of GI Function
up to 7 days of dosing or until hospital discharge
Secondary Outcomes (1)
Ancillary GI Functions
up to 7 days of dosing or hospital discharge
Study Arms (3)
Experimental 2
EXPERIMENTALexperimental 1
EXPERIMENTALPlacebo
PLACEBO COMPARATORPlacebo comparator daily (QD)
Interventions
Eligibility Criteria
You may qualify if:
- Men or women, 18 to 80 years of age, inclusive
- 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.
You may not qualify if:
- Weight more than 200kg (441 pounds)
- Pregnant or breastfeeding
- Known history of drug or alcohol abuse within the previous year.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tranzyme, Inc.lead
- Norginecollaborator
Study Sites (45)
Fountain Valley Regional Hospital
Fountain Valley, California, 92708, United States
Orange Coast Memorial Med. Ctr.
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
Related Publications (1)
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.
PMID: 23739196DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2011
First Posted
January 28, 2011
Study Start
January 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
July 26, 2012
Record last verified: 2012-07