Trials / Completed
CompletedNCT01296620
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
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 330 (actual)
- Sponsor
- Tranzyme, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ulimorelin Intravenously (IV) | 160 µg/kg daily (QD) |
| DRUG | Ulimorelin Invtravenously (IV) | 480 µg/kg daily (QD) |
| DRUG | 5% dextrose in water | Placebo |
Timeline
- Start date
- 2011-02-01
- Primary completion
- 2012-03-01
- Completion
- 2012-03-01
- First posted
- 2011-02-15
- Last updated
- 2012-07-26
Locations
50 sites across 6 countries: United States, Bulgaria, Czechia, France, Lithuania, Romania
Source: ClinicalTrials.gov record NCT01296620. Inclusion in this directory is not an endorsement.