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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

February 14, 2011
July 25, 2012
February 2011
March 2012   (final data collection date for primary outcome measure)
Recovery of GI Function [ Time Frame: up to 7 days of dosing or until hospital discharge ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01296620 on ClinicalTrials.gov Archive Site
Ancillary GI Functions [ Time Frame: up to 7 days of dosing or hospital discharge ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Gastrointestinal Dysmotility
  • Drug: Ulimorelin Intravenously (IV)
    160 µg/kg daily (QD)
  • Drug: Ulimorelin Invtravenously (IV)
    480 µg/kg daily (QD)
  • Drug: 5% dextrose in water
    Placebo
  • Experimental: Experimental 1
    Intervention: Drug: Ulimorelin Intravenously (IV)
  • Experimental: Experimental 2
    Intervention: Drug: Ulimorelin Invtravenously (IV)
  • Placebo Comparator: Placebo
    Intervention: Drug: 5% dextrose in water
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
330
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Bulgaria,   Czech Republic,   France,   Lithuania,   Romania
 
NCT01296620
TZP-101-CL-P008, 2010-023229-38
Not Provided
Tranzyme, Inc.
Tranzyme, Inc.
Norgine
Not Provided
Tranzyme, Inc.
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP