Ulimorelin Study of Efficacy and Safety (ULISES 007)

This study has been completed.
Sponsor:
Collaborator:
Norgine
Information provided by (Responsible Party):
Tranzyme, Inc.
ClinicalTrials.gov Identifier:
NCT01285570
First received: January 26, 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: 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: 332
Study Start Date: January 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental 2 Drug: Ulimorelin Intravenously (IV)
480 microg/kg daily (QD)
Experimental: experimental 1 Drug: Ulimorelin Intravenously (IV)
160 microg/kg daily (QD)
Placebo Comparator: Placebo
Placebo comparator daily (QD)
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: NCT01285570

  Show 45 Study Locations
Sponsors and Collaborators
Tranzyme, Inc.
Norgine
  More Information

No publications provided

Responsible Party: Tranzyme, Inc.
ClinicalTrials.gov Identifier: NCT01285570     History of Changes
Other Study ID Numbers: TZP-101-CL-P007
Study First Received: January 26, 2011
Last Updated: July 25, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 16, 2014