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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tranzyme, Inc.
ClinicalTrials.gov Identifier:
NCT00617552
First received: February 6, 2008
Last updated: December 5, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Postoperative Ileus
Drug: 5% dextrose in water
Drug: TZP-101
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Tranzyme, Inc.:

Primary Outcome Measures:
  • Time to recovery of gastrointestinal function as defined by the time to first bowel movement. [ Time Frame: 7 days of dosing plus 7 days after administration of last dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time to tolerance of first solid food [ Time Frame: 7 days post administration of last dose ] [ Designated as safety issue: No ]

Enrollment: 267
Study Start Date: July 2007
Study Completion Date: August 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: 5% dextrose in water
60 ml IV infusion over 30 minutes
Other Name: 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

Detailed Description:

Subjects will be randomized according to an adaptive randomization procedure.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617552

Locations
United States, California
Office of Dr. Phillip Fleshner
Los Angeles, California, United States, 90048
United States, Florida
University of Miami Clinic
Miami, Florida, United States, 33136
Renstar Medical Research
Ocala, Florida, United States, 34471
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Maryland
Univ. of Maryland, R.A. Cowley Shock Trauma Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Baystate Medical Center/Baystate Health
Springfield, Massachusetts, United States, 01199
United States, Michigan
Michigan State/Spectrum Health
Grand Rapids, Michigan, United States, 49503
United States, New York
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
United States, North Dakota
Mid Dakota Clinic, PC
Bismarck, North Dakota, United States, 58501
United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
India
St. John's Hospital
Bangalore, Karnataka, India
Stanley Medical College
Chennai, India, 600001
Amrita Institute of Medical Sciences
Cochin, India, 682026
Lakeshore Hospital
Cochin, India, 682304
Nizams Institute of Medical Science
Hyderabad, India, 500083
Mediciti Hospitals
Hyderabad, India, 50063
Asian Institute of Gastroenterology
Hyderabad, India, 500082
Sanjay Gandhi Post-Graduate Institute of Medical Sciences
Lucknow, India, 226014
Romania
Spitalul Urg. SF. Pantelimon
Bucharest, Romania, 021659 RO
Spitalul Universitar Elias
Bucharest, Romania
Clinica de Chirugie Generala I, Spitalul Universitar
Bucuresti, Romania, 00000 RO
Clinica de Chirugie General IV, Spitalul Universitar
Bucuresti, Romania, 00000 RO
Spitalul Clinic Colentina
Bucuresti, Romania, 00000 RO
Spitalul Clinic Coltea
Bucuresti, Romania, 00000 RO
Spitalul Clinic de Urgenta Floreasca
Bucuresti, Romania, 00000 RO
Clinica de Chirugie Generala III, Spitalul Universitar
Bucuresti, Romania, 00000 RO
Institul Clinic Fundeni
Bucuresti, Romania, 00000 RO
Sponsors and Collaborators
Tranzyme, Inc.
  More Information

No publications provided

Responsible Party: Tranzyme, Inc.
ClinicalTrials.gov Identifier: NCT00617552     History of Changes
Other Study ID Numbers: TZP-101-CL-P005
Study First Received: February 6, 2008
Last Updated: December 5, 2012
Health Authority: United States: Food and Drug Administration
Romania: National Medicines Agency
Lithuania: State Medicine Control Agency - Ministry of Health
India: Drugs Controller General of India

Keywords provided by Tranzyme, Inc.:
postoperative ileus
POI
major open abdominal surgery

Additional relevant MeSH terms:
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 24, 2014