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Ulimorelin Study of Efficacy and Safety (ULISES 008)

Sponsor
Tranzyme, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01296620
Collaborator
Norgine (Industry)
330
Enrollment
50
Locations
3
Arms
12.9
Duration (Months)
6.6
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: Ulimorelin Intravenously (IV)
  • Drug: Ulimorelin Invtravenously (IV)
  • Drug: 5% dextrose in water
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
330 participants
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
Study Start Date :
Feb 1, 2011
Actual Primary Completion Date :
Mar 1, 2012
Actual Study Completion Date :
Mar 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Recovery of GI Function [up to 7 days of dosing or until hospital discharge]

Secondary Outcome Measures

  1. Ancillary GI Functions [up to 7 days of dosing or hospital discharge]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Glendale Memorial Hospital Glendale California United States 91204
2 Long Beach Memorial Medical Center Long Beach California United States 90806
3 Univ. of Southern California Los Angeles California United States 90033
4 Cedars Sinai Medical Center Los Angeles California United States 90048
5 Palo Alto VA Health Care Ctr Palo Alto California United States 94304
6 Citrus Memorial Hospital Inverness Florida United States 34452
7 Pensacola Research Consultants Pensacola Florida United States 32504
8 Tampa General Hospital Tampa Florida United States 33606
9 ARS Clinical Trials Powder Springs Georgia United States 30127
10 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
11 NOLA CVT Surgery New Orleans Louisiana United States 70115
12 Tufts Medical Center Boston Massachusetts United States 02111
13 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
14 CRC of Jackson Jackson Mississippi United States 39202
15 Mount Sinai Hospital New York New York United States 10021
16 Sanford Medical Center Fargo North Dakota United States 58122
17 Kaiser Permanente Northwest Clackamas Oregon United States 34452
18 Oregon Health and Science University Portland Oregon United States 97239
19 Forbes Regional Hospita Monroeville Pennsylvania United States 15146
20 Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
21 VA Pittsburgh Health Care System Pittsburgh Pennsylvania United States 15241
22 Access Clinical Trials, Inc. Nashville Tennessee United States 37203
23 Texas Tech University Health Sciences Center El Paso Texas United States 79905
24 Southwest Surgical Associates Houston Texas United States 77074
25 VCU Medical Center Richmond Virginia United States 23219
26 MultiCare Research Institute Tacoma Washington United States 98405
27 UMHAT Emergency Medicine Sifua Bulgaria
28 MHAT Tokuda Hospital Sofia Sofia Bulgaria
29 Military Medical Academy Sofia Bulgaria
30 UMHAT Tzaritza Yoanna ISUL Sofia Bulgaria
31 UMHAT St. Marina Varna Bulgaria
32 FN Brno Brno Czech Republic
33 St. Anne's University Hospital Brno Czech Republic
34 Hospital Jihlava Jihlava Czech Republic
35 Hospital Liberec Liberec Czech Republic
36 FN Olomouc Olomouc Czech Republic
37 Fakutni Thomayerova nemocnica Prague Czech Republic
38 University Hospital Bulovka Prague Czech Republic
39 CHU Avicenne Bobigny France
40 Hopital Beaujon Clichy Paris France
41 CHRU Lille Lille France
42 CHU Rouen, Hopital Charles Nicolle Rouen France
43 Kaunas Clinical Hospital No. 2 Kaunas Lithuania LT-47144
44 Kaunas Medical University Clinics Kaunas Lithuania LT50009
45 Republican Klaipeda Hospital Klaipeda Lithuania LT-92231
46 Klaipeda Hospital Klaipeda Lithuania LT-92288
47 Institute of Oncology at Vilnius University, Clinic of Surgery Vilnius Lithuania LT-08660
48 Vilnius City Univ. Hospital Clinic of Surgery Vilnius Lithuania LT-10207
49 Institute regional de Gastroenterologie si Hepatologie Cluj Napoca Romania
50 Spitalul Clinic Judetean de Urgenta Oradea Romania

Sponsors and Collaborators

  • Tranzyme, Inc.
  • Norgine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tranzyme, Inc.
ClinicalTrials.gov Identifier:
NCT01296620
Other Study ID Numbers:
  • TZP-101-CL-P008
  • 2010-023229-38
First Posted:
Feb 15, 2011
Last Update Posted:
Jul 26, 2012
Last Verified:
Jul 1, 2012

Study Results

No Results Posted as of Jul 26, 2012