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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01296620

Enrollment

330

Registered

2011-02-15

Start date

2011-02-28

Completion date

2012-03-31

Last updated

2012-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Dysmotility

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

Interventions

DRUGUlimorelin Intravenously (IV)

160 µg/kg daily (QD)

DRUGUlimorelin Invtravenously (IV)

480 µg/kg daily (QD)

DRUG5% dextrose in water

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Recovery of GI Function	up to 7 days of dosing or until hospital discharge

Secondary

Measure	Time frame
Ancillary GI Functions	up to 7 days of dosing or hospital discharge

Countries

Bulgaria, Czechia, France, Lithuania, Romania, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026