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Ulimorelin Study of Efficacy and Safety (ULISES 008)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01296620
First Posted: February 15, 2011
Last Update Posted: July 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Norgine
Information provided by (Responsible Party):
Tranzyme, Inc.
February 14, 2011
February 15, 2011
July 26, 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 ]
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 ]
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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Shaw M, Pediconi C, McVey D, Mondou E, Quinn J, Chamblin B, Rousseau F. Safety and efficacy of ulimorelin administered postoperatively to accelerate recovery of gastrointestinal motility following partial bowel resection: results of two randomized, placebo-controlled phase 3 trials. Dis Colon Rectum. 2013 Jul;56(7):888-97. doi: 10.1097/DCR.0b013e31829196d0.

*   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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Czech Republic,   France,   Lithuania,   Romania,   United States
 
 
NCT01296620
TZP-101-CL-P008
2010-023229-38 ( EudraCT Number )
Not Provided
Not Provided
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