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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
History of Changes
  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:

Drug Information available for: Dextrose
U.S. FDA Resources

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
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 May 23, 2013