Ulimorelin Study of Efficacy and Safety (ULISES 008)

This study has been completed.
Sponsor:
Collaborator:
Norgine
Information provided by (Responsible Party):
Tranzyme, Inc.
ClinicalTrials.gov Identifier:
NCT01296620
First received: February 14, 2011
Last updated: July 25, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention Phase
Gastrointestinal Dysmotility
Drug: Ulimorelin Intravenously (IV)
Drug: Ulimorelin Invtravenously (IV)
Drug: 5% dextrose in water
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Tranzyme, Inc.:

Primary Outcome Measures:
  • Recovery of GI Function [ Time Frame: up to 7 days of dosing or until hospital discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ancillary GI Functions [ Time Frame: up to 7 days of dosing or hospital discharge ] [ Designated as safety issue: No ]

Enrollment: 330
Study Start Date: February 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental 1 Drug: Ulimorelin Intravenously (IV)
160 µg/kg daily (QD)
Experimental: Experimental 2 Drug: Ulimorelin Invtravenously (IV)
480 µg/kg daily (QD)
Placebo Comparator: Placebo Drug: 5% dextrose in water
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Weight more than 200kg (441 pounds)
  • Pregnant or breastfeeding
  • Known history of drug or alcohol abuse within the previous year
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01296620

  Hide Study Locations
Locations
United States, California
Glendale Memorial Hospital
Glendale, California, United States, 91204
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
Univ. of Southern California
Los Angeles, California, United States, 90033
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Palo Alto VA Health Care Ctr
Palo Alto, California, United States, 94304
United States, Florida
Citrus Memorial Hospital
Inverness, Florida, United States, 34452
Pensacola Research Consultants
Pensacola, Florida, United States, 32504
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Georgia
ARS Clinical Trials
Powder Springs, Georgia, United States, 30127
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Louisiana
NOLA CVT Surgery
New Orleans, Louisiana, United States, 70115
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Mississippi
CRC of Jackson
Jackson, Mississippi, United States, 39202
United States, New York
Mount Sinai Hospital
New York, New York, United States, 10021
United States, North Dakota
Sanford Medical Center
Fargo, North Dakota, United States, 58122
United States, Oregon
Kaiser Permanente Northwest
Clackamas, Oregon, United States, 34452
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Forbes Regional Hospita
Monroeville, Pennsylvania, United States, 15146
VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, United States, 15241
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Tennessee
Access Clinical Trials, Inc.
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Tech University Health Sciences Center
El Paso, Texas, United States, 79905
Southwest Surgical Associates
Houston, Texas, United States, 77074
United States, Virginia
VCU Medical Center
Richmond, Virginia, United States, 23219
United States, Washington
MultiCare Research Institute
Tacoma, Washington, United States, 98405
Bulgaria
UMHAT Emergency Medicine
Sifua, Bulgaria
Military Medical Academy
Sofia, Bulgaria
UMHAT Tzaritza Yoanna ISUL
Sofia, Bulgaria
MHAT Tokuda Hospital Sofia
Sofia, Bulgaria
UMHAT St. Marina
Varna, Bulgaria
Czech Republic
FN Brno
Brno, Czech Republic
St. Anne's University Hospital
Brno, Czech Republic
Hospital Jihlava
Jihlava, Czech Republic
Hospital Liberec
Liberec, Czech Republic
FN Olomouc
Olomouc, Czech Republic
University Hospital Bulovka
Prague, Czech Republic
Fakutni Thomayerova nemocnica
Prague, Czech Republic
France
CHU Avicenne
Bobigny, France
Hopital Beaujon
Clichy Paris, France
CHRU Lille
Lille, France
CHU Rouen, Hopital Charles Nicolle
Rouen, France
Lithuania
Kaunas Medical University Clinics
Kaunas, Lithuania, LT50009
Kaunas Clinical Hospital No. 2
Kaunas, Lithuania, LT-47144
Republican Klaipeda Hospital
Klaipeda, Lithuania, LT-92231
Klaipeda Hospital
Klaipeda, Lithuania, LT-92288
Institute of Oncology at Vilnius University, Clinic of Surgery
Vilnius, Lithuania, LT-08660
Vilnius City Univ. Hospital Clinic of Surgery
Vilnius, Lithuania, LT-10207
Romania
Institute regional de Gastroenterologie si Hepatologie
Cluj Napoca, Romania
Spitalul Clinic Judetean de Urgenta
Oradea, Romania
Sponsors and Collaborators
Tranzyme, Inc.
Norgine
  More Information

No publications provided

Responsible Party: Tranzyme, Inc.
ClinicalTrials.gov Identifier: NCT01296620     History of Changes
Other Study ID Numbers: TZP-101-CL-P008, 2010-023229-38
Study First Received: February 14, 2011
Last Updated: July 25, 2012
Health Authority: United States: Food and Drug Administration
Lithuania: State Medicines Control Agency

ClinicalTrials.gov processed this record on July 26, 2014