Safety and Efficacy of IV Infusion of TZP-101 for POI After Major Open Abdominal Surgery
NCT ID: NCT00617552
Last Updated: 2012-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
267 participants
INTERVENTIONAL
2007-07-31
2008-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
5% dextrose in water
60 ml IV infusion over 30 minutes
2
TZP-101
20 micrograms/kg IV 2ml/minute for 30 minutes
3
TZP-101
40 micrograms/kg IV 2 ml/minute for 30 minutes
4
TZP-101
80 micrograms/kg IV 2ml/minute for 30 minutes
5
TZP-101
160 micrograms/kg IV 2ml/minute over 30 minutes
6
TZP-101
320 micrograms/kg IV 2ml/minute for 30 minutes
7
TZP-101
480 micrograms/kg IV 2ml/minute over 30 minutes
8
TZP-101
600 micrograms/kg IV 2ml/minute for 30 minutes
Interventions
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5% dextrose in water
60 ml IV infusion over 30 minutes
TZP-101
20 micrograms/kg IV 2ml/minute for 30 minutes
TZP-101
40 micrograms/kg IV 2 ml/minute for 30 minutes
TZP-101
80 micrograms/kg IV 2ml/minute for 30 minutes
TZP-101
160 micrograms/kg IV 2ml/minute over 30 minutes
TZP-101
320 micrograms/kg IV 2ml/minute for 30 minutes
TZP-101
480 micrograms/kg IV 2ml/minute over 30 minutes
TZP-101
600 micrograms/kg IV 2ml/minute for 30 minutes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Tranzyme, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Spitalul Urg. SF. Pantelimon
Bucharest, , Romania
Spitalul Universitar Elias
Bucharest, , Romania
Countries
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Other Identifiers
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TZP-101-CL-P005
Identifier Type: -
Identifier Source: org_study_id