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

T

Tranzyme

Status and phase

Completed

Phase 2

Conditions

Postoperative Ileus

Treatments

Drug: 5% dextrose in water

Drug: TZP-101

Study type

Interventional

Funder types

Industry

Identifiers

NCT00617552

TZP-101-CL-P005

Details and patient eligibility

About

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).

Full description

Subjects will be randomized according to an adaptive randomization procedure.

Enrollment

267 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

267 participants in 8 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Drug: 5% dextrose in water

2

Experimental group

Treatment:

Drug: TZP-101

3

Experimental group

Treatment:

Drug: TZP-101

4

Experimental group

Treatment:

Drug: TZP-101

5

Experimental group

Treatment:

Drug: TZP-101

6

Experimental group

Treatment:

Drug: TZP-101

7

Experimental group

Treatment:

Drug: TZP-101

8

Experimental group

Treatment:

Drug: TZP-101

Trial contacts and locations

27

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