Ulimorelin Study of Efficacy and Safety (ULISES 008)

Tranzyme

Status and phase: Completed; Phase 3

Conditions: Gastrointestinal Dysmotility

Treatments: Drug: 5% dextrose in water; Drug: Ulimorelin Intravenously (IV); Drug: Ulimorelin Invtravenously (IV)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01296620

2010-023229-38 (EudraCT Number)

TZP-101-CL-P008

Details and patient eligibility

About

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

Enrollment: 330 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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330 participants in 3 patient groups, including a placebo group

Experimental 1

Experimental group

Treatment:

Drug: Ulimorelin Intravenously (IV)

Experimental 2

Experimental group

Treatment:

Drug: Ulimorelin Invtravenously (IV)

Placebo

Placebo Comparator group

Treatment:

Drug: 5% dextrose in water