Safety and Efficacy of IV Infusion of TZP-101 for POI After Major Open Abdominal Surgery

Sponsor

Tranzyme, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00617552

Collaborator

(none)

267

Enrollment

Locations

Arms

Duration (Months)

9.9

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether TZP-101 is effective in the management of post operative ileus in subjects undergoing major open abdominal surgery (i.e. partial large bowel resection).

Condition or Disease	Intervention/Treatment	Phase
Postoperative Ileus	Drug: 5% dextrose in water Drug: TZP-101 Drug: TZP-101 Drug: TZP-101 Drug: TZP-101 Drug: TZP-101 Drug: TZP-101 Drug: TZP-101	Phase 2

Detailed Description

Subjects will be randomized according to an adaptive randomization procedure.

Study Design

Study Type:

Interventional

Actual Enrollment :

267 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess Efficacy and Safety of TZP-101 When Administered as 30 Minute i.v. Infusion for POI to Subjects Undergoing Major Open Abdominal Surgery

Study Start Date :

Jul 1, 2007

Actual Primary Completion Date :

Jul 1, 2008

Actual Study Completion Date :

Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1	Drug: 5% dextrose in water 60 ml IV infusion over 30 minutes Other Names: D5W
Experimental: 2	Drug: TZP-101 20 micrograms/kg IV 2ml/minute for 30 minutes
Experimental: 3	Drug: TZP-101 40 micrograms/kg IV 2 ml/minute for 30 minutes
Experimental: 4	Drug: TZP-101 80 micrograms/kg IV 2ml/minute for 30 minutes
Experimental: 5	Drug: TZP-101 160 micrograms/kg IV 2ml/minute over 30 minutes
Experimental: 6	Drug: TZP-101 320 micrograms/kg IV 2ml/minute for 30 minutes
Experimental: 7	Drug: TZP-101 480 micrograms/kg IV 2ml/minute over 30 minutes
Experimental: 8	Drug: TZP-101 600 micrograms/kg IV 2ml/minute for 30 minutes

Outcome Measures

Primary Outcome Measures

Time to recovery of gastrointestinal function as defined by the time to first bowel movement. [7 days of dosing plus 7 days after administration of last dose]

Secondary Outcome Measures

time to tolerance of first solid food [7 days post administration of last dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects who meet all of the following inclusion criteria may be enrolled in the study:

Male or Female, 18 to 80 years of age, inclusive
If female, post-menopausal for the past 12 months, surgically sterile (i.e. tubal ligation, hysterectomy), or using an adequate method of birth control (i.e., oral contraceptives, double barrier method, IUD cover or sterilized partner
Subject is scheduled to undergo a partial large bowel resection with primary anastomosis - See Appendix II
Subject's body weight is ≤100kg
Subject is scheduled to receive postoperative pain management with i.v. opioids
Subject is scheduled to have nasogastric tube removed at the end of surgery
Subject is scheduled to be offered liquids on postoperative day 1
Subject is scheduled to be encouraged for ambulation on postoperative day 1
Subject is scheduled to be offered solid food on postoperative day 2

Exclusion Criteria:

Subjects who meet any of the following exclusion criteria may not be enrolled in the study:

A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450(men)/ >470(women) milliseconds)
Subject has history of additional risk factors for Torsades de Pointes (heart failure, hypokalemia, family history of Long QT Syndrome)
Subject requires use of concomitant medication that prolongs the QT interval - List provided in Study Procedures Manual
Subject requires use of concomitant medication that is a known to interact with isoenzyme CYP3A4
Subject has complete bowel obstruction
Subject is scheduled to receive a thoracic epidural
Subject is scheduled to receive total colectomy, colostomy, or ileostomy
Subject is scheduled to receive a lower anterior resection
Subject is scheduled for laparoscopic procedure
Subject is scheduled to receive prophylactic antiemetics post surgery; however subjects may receive intraoperatively as part of the anesthesia protocol and postoperative antiemetics for symptomatic treatment
Subject has significant impairment of liver or renal function (ALT/AST 2 ½ times the upper limit of normal; creatinine clearance < 50mL/min.)
Subject has a psychiatric disorder or cognitive impairment that would interfere with participation in the study
Subject has severe cardiovascular, pulmonary, hematological diseases
Subject has participated in an investigational study 30 days prior or received TZP-101 90 days prior to the study initiation
Subject is pregnant (confirmed by quantitative serum pregnancy test) or is breast-feeding
Subject has a known history of Hep B, Hep C or HIV
Subject has a known history of drug or alcohol abuse
Subject has a recent, adult history of clinically significant hypersensitivity reaction(s) to any drug

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Office of Dr. Phillip Fleshner	Los Angeles	California	United States	90048
2	University of Miami Clinic	Miami	Florida	United States	33136
3	Renstar Medical Research	Ocala	Florida	United States	34471
4	Northwestern University	Chicago	Illinois	United States	60611
5	Univ. of Maryland, R.A. Cowley Shock Trauma Center	Baltimore	Maryland	United States	21201
6	Baystate Medical Center/Baystate Health	Springfield	Massachusetts	United States	01199
7	Michigan State/Spectrum Health	Grand Rapids	Michigan	United States	49503
8	Stony Brook University Hospital	Stony Brook	New York	United States	11794
9	Mid Dakota Clinic, PC	Bismarck	North Dakota	United States	58501
10	The Methodist Hospital	Houston	Texas	United States	77030
11	St. John's Hospital	Bangalore	Karnataka	India
12	Stanley Medical College	Chennai		India	600001
13	Amrita Institute of Medical Sciences	Cochin		India	682026
14	Lakeshore Hospital	Cochin		India	682304
15	Asian Institute of Gastroenterology	Hyderabad		India	500082
16	Nizams Institute of Medical Science	Hyderabad		India	500083
17	Mediciti Hospitals	Hyderabad		India	50063
18	Sanjay Gandhi Post-Graduate Institute of Medical Sciences	Lucknow		India	226014
19	Spitalul Urg. SF. Pantelimon	Bucharest		Romania	021659 RO
20	Spitalul Universitar Elias	Bucharest		Romania
21	Clinica de Chirugie General IV, Spitalul Universitar	Bucuresti		Romania	00000 RO
22	Clinica de Chirugie Generala I, Spitalul Universitar	Bucuresti		Romania	00000 RO
23	Clinica de Chirugie Generala III, Spitalul Universitar	Bucuresti		Romania	00000 RO
24	Institul Clinic Fundeni	Bucuresti		Romania	00000 RO
25	Spitalul Clinic Colentina	Bucuresti		Romania	00000 RO
26	Spitalul Clinic Coltea	Bucuresti		Romania	00000 RO
27	Spitalul Clinic de Urgenta Floreasca	Bucuresti		Romania	00000 RO

Sponsors and Collaborators

Tranzyme, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tranzyme, Inc.

ClinicalTrials.gov Identifier:

NCT00617552

Other Study ID Numbers:

TZP-101-CL-P005

First Posted:

Feb 18, 2008

Last Update Posted:

Dec 7, 2012

Last Verified:

Dec 1, 2012

Keywords provided by Tranzyme, Inc.

postoperative ileus

POI

major open abdominal surgery

Additional relevant MeSH terms:

Ileus

Study Results

No Results Posted as of Dec 7, 2012