Ulimorelin Study of Efficacy and Safety (ULISES 008)
Completed · Phase 3 · Has a placebo group
Conditions studied: Gastrointestinal Dysmotility
In brief
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
Key facts
- Study ID
- NCT01296620
- Run by
- Tranzyme, Inc.
- People needed
- 330
- Starts
- 2011-02-01
- Expected to finish
- 2012-03-01
- Last updated by the study team
- 2012-07-26
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- 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
Full record on ClinicalTrials.gov
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