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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.
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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

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 ]

Secondary Outcome Measures:
  • Ancillary GI Functions [ Time Frame: up to 7 days of dosing or hospital discharge ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01296620


  Show 50 Study Locations
Sponsors and Collaborators
Tranzyme, Inc.
Norgine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tranzyme, Inc.
ClinicalTrials.gov Identifier: NCT01296620     History of Changes
Other Study ID Numbers: TZP-101-CL-P008
2010-023229-38 ( EudraCT Number )
First Submitted: February 14, 2011
First Posted: February 15, 2011
Last Update Posted: July 26, 2012
Last Verified: July 2012