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

Completed · Phase 2

Conditions studied: Postoperative Ileus

In brief

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).

Key facts

Study ID

NCT00617552

Run by

Tranzyme, Inc.

People needed

267

Starts

2007-07-01

Expected to finish

2008-08-01

Last updated by the study team

2012-12-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Office of Dr. Phillip Fleshner — Los Angeles, California, United States
• University of Miami Clinic — Miami, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Univ. of Maryland, R.A. Cowley Shock Trauma Center — Baltimore, Maryland, United States
• Baystate Medical Center/Baystate Health — Springfield, Massachusetts, United States
• Michigan State/Spectrum Health — Grand Rapids, Michigan, United States
• Stony Brook University Hospital — Stony Brook, New York, United States
• Mid Dakota Clinic, PC — Bismarck, North Dakota, United States
• The Methodist Hospital — Houston, Texas, United States
• St. John's Hospital — Bangalore, Karnataka, India
• Stanley Medical College — Chennai, India
• Asian Institute of Gastroenterology — Hyderabad, India
• Nizams Institute of Medical Science — Hyderabad, India
• Mediciti Hospitals — Hyderabad, India
• Amrita Institute of Medical Sciences — Kochi, India
• Lakeshore Hospital — Kochi, India
• Sanjay Gandhi Post-Graduate Institute of Medical Sciences — Lucknow, India
• Clinica de Chirugie General IV, Spitalul Universitar — Bucharest, Romania
• Clinica de Chirugie Generala I, Spitalul Universitar — Bucharest, Romania
• Clinica de Chirugie Generala III, Spitalul Universitar — Bucharest, Romania
• Institul Clinic Fundeni — Bucharest, Romania
• Spitalul Clinic Colentina — Bucharest, Romania
• Spitalul Clinic Coltea — Bucharest, Romania
• Spitalul Clinic de Urgenta Floreasca — Bucharest, Romania

Full record on ClinicalTrials.gov

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