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Ulimorelin Study of Efficacy and Safety (ULISES 008)

This study has been completed.
Information provided by (Responsible Party):
Tranzyme, Inc. Identifier:
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 ]
Same as current
Complete list of historical versions of study NCT01296620 on 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
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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
  • 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 Identifier (NCT Number) in Medline.
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)
Contact information is only displayed when the study is recruiting subjects
United States,   Bulgaria,   Czech Republic,   France,   Lithuania,   Romania
2010-023229-38 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Not Provided
Tranzyme, Inc.
Tranzyme, Inc.
Not Provided
Tranzyme, Inc.
July 2012

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