Ulimorelin Study of Efficacy and Safety (ULISES 008)

This study has been completed.
Sponsor:
Collaborator:
Norgine
Information provided by (Responsible Party):
Tranzyme, Inc.
ClinicalTrials.gov Identifier:
NCT01296620
First received: February 14, 2011
Last updated: July 25, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention Phase
Gastrointestinal Dysmotility
Drug: Ulimorelin Intravenously (IV)
Drug: Ulimorelin Invtravenously (IV)
Drug: 5% dextrose in water
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Tranzyme, Inc.:

Primary Outcome Measures:
  • Recovery of GI Function [ Time Frame: up to 7 days of dosing or until hospital discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ancillary GI Functions [ Time Frame: up to 7 days of dosing or hospital discharge ] [ Designated as safety issue: No ]

Enrollment: 330
Study Start Date: February 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental 1 Drug: Ulimorelin Intravenously (IV)
160 µg/kg daily (QD)
Experimental: Experimental 2 Drug: Ulimorelin Invtravenously (IV)
480 µg/kg daily (QD)
Placebo Comparator: Placebo Drug: 5% dextrose in water
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01296620

  Show 50 Study Locations
Sponsors and Collaborators
Tranzyme, Inc.
Norgine
  More Information

No publications provided

Responsible Party: Tranzyme, Inc.
ClinicalTrials.gov Identifier: NCT01296620     History of Changes
Other Study ID Numbers: TZP-101-CL-P008, 2010-023229-38
Study First Received: February 14, 2011
Last Updated: July 25, 2012
Health Authority: United States: Food and Drug Administration
Lithuania: State Medicines Control Agency

ClinicalTrials.gov processed this record on October 23, 2014