Ulimorelin Study of Efficacy and Safety (ULISES 007)

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

NCT01285570

Run by

Tranzyme, Inc.

People needed

332

Starts

2011-01-01

Expected to finish

2012-01-01

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

• 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

Full record on ClinicalTrials.gov

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