Ulimorelin Study of Efficacy and Safety (ULISES 007)

• Sponsor: Tranzyme, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01285570
• Collaborator: Norgine (Industry)
• Enrollment: 332
• Locations: 45
• Arms: 3
• Duration (Months): 12
• Patients Per Site: 7.4
• Patients Per Site Per Month: 0.6

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
Gastrointestinal Dysmotility	Drug: Ulimorelin Intravenously (IV); Drug: Ulimorelin Intravenously (IV); Drug: 5% dextrose in water	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 332 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: Jan 1, 2011
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental 2	Drug: Ulimorelin Intravenously (IV); 480 microg/kg daily (QD)
Experimental: experimental 1	Drug: Ulimorelin Intravenously (IV); 160 microg/kg daily (QD)
Placebo Comparator: Placebo Placebo comparator daily (QD)	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	Fountain Valley Regional Hospital	Fountain Valley	California	United States	92708
2	Orange Coast Memorial Med. Ctr.	Fountain Valley	California	United States	92708
3	USC, Colorectal Surgery Division	Los Angeles	California	United States	90033
4	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
5	Denver VA Medical Center	Denver	Colorado	United States	80220
6	Nature Coast Clinical Research	Inverness	Florida	United States	34452
7	Jacksonville Center for Clinical Research	Jacksonville	Florida	United States	32216
8	Pensacola Research Consultants	Pensacola	Florida	United States	32504
9	Sunrise Clinical Research, Inc.	Sunrise	Florida	United States	33323
10	ARS Clinical Trials	Powder Springs	Georgia	United States	30127
11	So. Illinois Univ. School of Medicine	Springfield	Illinois	United States	62702
12	Univ. of Louisville, Dept. of Surgery	Louisville	Kentucky	United States	40202
13	UMass Memorial Medical Center	Worcester	Massachusetts	United States	01655
14	CRC of Jackson	Jackson	Mississippi	United States	39202
15	Creighton Univ. Medical Ctr.	Omaha	Nebraska	United States	68121
16	Mt. Sinai Hospital	New York	New York	United States	10021
17	Duke University Medical Center	Durham	North Carolina	United States	27710
18	University Hospitals Case Medical Ctr.	Cleveland	Ohio	United States	44106
19	Bend Memorial Clinic	Bend	Oregon	United States	97701
20	Mt. Talbert Medical Offices	Clackamas	Oregon	United States	97015
21	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033-0850
22	JPS Health Network, Dept. of Surgery	Fort Worth	Texas	United States	76104
23	Southwest Surgical Associates	Houston	Texas	United States	77074
24	JohnFerenc Del-pesti Hospital	Budapest		Hungary
25	Petz Aladar County Education Hospital	Gyor		Hungary
26	County Hospital of Kecskemet	Kecskemet		Hungary
27	St. Gyorgy Hospital of Fejer County	Szekesfehervar		Hungary
28	Fondazione I.R.C.C.S. Policlinico San Matteo	Pavia		Italy
29	Policlinico Universitario Agostino Gemelli -Univ	Rome		Italy
30	IRCCS Policlinico San Donato	San Donato		Italy
31	Plac Hallera, Genl Surgery	Lodz		Poland
32	Univ. Hospital #1, N. Barlicki Med. Univ.	Lodz		Poland
33	Hospital Wolski	Warsaw		Poland
34	Spitalul Clinic de Urgenta "Prof. Dr. Octavian Fodor"	Cluj Napoca		Romania
35	Spitalul Clinic Judetean de Urgente	Iasi		Romania
36	Spitalul Clinic Judetean de Urgenta Oradea	Oradea		Romania
37	Spitalul Clinic Judetean Mures	Targu Mures		Romania
38	Spitalul Clinic Judetean de Urgenta Timisoara	Timisoara		Romania
39	Clinical Center of Serbia	Belgrade		Serbia
40	Clinical Hospital Bezanijska Kosa	Belgrade		Serbia
41	Clinical Hospital Center Zvezdara	Belgrade		Serbia
42	Clinical Center Nis	Nis		Serbia
43	Nottingham University Hospital	Nottingham		United Kingdom
44	Scarborough Hospital	Scarborough		United Kingdom
45	Northern General Hospital	Sheffield		United Kingdom

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: NCT01285570
• Other Study ID Numbers: TZP-101-CL-P007
• First Posted: Jan 28, 2011
• Last Update Posted: Jul 26, 2012
• Last Verified: Jul 1, 2012

Study Results

No Results Posted as of Jul 26, 2012