Ulimorelin Study of Efficacy and Safety (ULISES 008)
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
2 other identifiers
interventional
330
6 countries
50
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 Feb 2011
Shorter than P25 for phase_3
50 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
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 14, 2011
CompletedFirst Posted
Study publicly available on registry
February 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedJuly 26, 2012
July 1, 2012
1.1 years
February 14, 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 1
EXPERIMENTALExperimental 2
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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 (50)
Glendale Memorial Hospital
Glendale, California, 91204, United States
Long Beach Memorial Medical Center
Long Beach, California, 90806, United States
Univ. of Southern California
Los Angeles, California, 90033, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Palo Alto VA Health Care Ctr
Palo Alto, California, 94304, United States
Citrus Memorial Hospital
Inverness, Florida, 34452, United States
Pensacola Research Consultants
Pensacola, Florida, 32504, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
ARS Clinical Trials
Powder Springs, Georgia, 30127, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
NOLA CVT Surgery
New Orleans, Louisiana, 70115, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
CRC of Jackson
Jackson, Mississippi, 39202, United States
Mount Sinai Hospital
New York, New York, 10021, United States
Sanford Medical Center
Fargo, North Dakota, 58122, United States
Kaiser Permanente Northwest
Clackamas, Oregon, 34452, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Forbes Regional Hospita
Monroeville, Pennsylvania, 15146, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, 15241, United States
Access Clinical Trials, Inc.
Nashville, Tennessee, 37203, United States
Texas Tech University Health Sciences Center
El Paso, Texas, 79905, United States
Southwest Surgical Associates
Houston, Texas, 77074, United States
VCU Medical Center
Richmond, Virginia, 23219, United States
MultiCare Research Institute
Tacoma, Washington, 98405, 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, LT-47144, Lithuania
Kaunas Medical University Clinics
Kaunas, LT50009, Lithuania
Republican Klaipeda Hospital
Klaipėda, LT-92231, Lithuania
Klaipeda Hospital
Klaipėda, LT-92288, Lithuania
Institute of Oncology at Vilnius University, Clinic of Surgery
Vilnius, LT-08660, Lithuania
Vilnius City Univ. Hospital Clinic of Surgery
Vilnius, LT-10207, Lithuania
Institute regional de Gastroenterologie si Hepatologie
Cluj-Napoca, Romania
Spitalul Clinic Judetean de Urgenta
Oradea, Romania
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
February 14, 2011
First Posted
February 15, 2011
Study Start
February 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
July 26, 2012
Record last verified: 2012-07