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

Primary Purpose

Postoperative Ileus

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
5% dextrose in water
TZP-101
TZP-101
TZP-101
TZP-101
TZP-101
TZP-101
TZP-101
Sponsored by
Tranzyme, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Ileus focused on measuring postoperative ileus, POI, major open abdominal surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Office of Dr. Phillip Fleshner
  • University of Miami Clinic
  • Renstar Medical Research
  • Northwestern University
  • Univ. of Maryland, R.A. Cowley Shock Trauma Center
  • Baystate Medical Center/Baystate Health
  • Michigan State/Spectrum Health
  • Stony Brook University Hospital
  • Mid Dakota Clinic, PC
  • The Methodist Hospital
  • St. John's Hospital
  • Stanley Medical College
  • Amrita Institute of Medical Sciences
  • Lakeshore Hospital
  • Asian Institute of Gastroenterology
  • Nizams Institute of Medical Science
  • Mediciti Hospitals
  • Sanjay Gandhi Post-Graduate Institute of Medical Sciences
  • Spitalul Urg. SF. Pantelimon
  • Spitalul Universitar Elias
  • Clinica de Chirugie General IV, Spitalul Universitar
  • Clinica de Chirugie Generala I, Spitalul Universitar
  • Clinica de Chirugie Generala III, Spitalul Universitar
  • Institul Clinic Fundeni
  • Spitalul Clinic Colentina
  • Spitalul Clinic Coltea
  • Spitalul Clinic de Urgenta Floreasca

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

5

6

7

8

Arm Description

Outcomes

Primary Outcome Measures

Time to recovery of gastrointestinal function as defined by the time to first bowel movement.

Secondary Outcome Measures

time to tolerance of first solid food

Full Information

First Posted
February 6, 2008
Last Updated
December 5, 2012
Sponsor
Tranzyme, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00617552
Brief Title
Safety and Efficacy of IV Infusion of TZP-101 for POI After Major Open Abdominal Surgery
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 Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tranzyme, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. 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).
Detailed Description
Subjects will be randomized according to an adaptive randomization procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Ileus
Keywords
postoperative ileus, POI, major open abdominal surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
267 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Experimental
Arm Title
5
Arm Type
Experimental
Arm Title
6
Arm Type
Experimental
Arm Title
7
Arm Type
Experimental
Arm Title
8
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
5% dextrose in water
Other Intervention Name(s)
D5W
Intervention Description
60 ml IV infusion over 30 minutes
Intervention Type
Drug
Intervention Name(s)
TZP-101
Intervention Description
20 micrograms/kg IV 2ml/minute for 30 minutes
Intervention Type
Drug
Intervention Name(s)
TZP-101
Intervention Description
40 micrograms/kg IV 2 ml/minute for 30 minutes
Intervention Type
Drug
Intervention Name(s)
TZP-101
Intervention Description
80 micrograms/kg IV 2ml/minute for 30 minutes
Intervention Type
Drug
Intervention Name(s)
TZP-101
Intervention Description
160 micrograms/kg IV 2ml/minute over 30 minutes
Intervention Type
Drug
Intervention Name(s)
TZP-101
Intervention Description
320 micrograms/kg IV 2ml/minute for 30 minutes
Intervention Type
Drug
Intervention Name(s)
TZP-101
Intervention Description
480 micrograms/kg IV 2ml/minute over 30 minutes
Intervention Type
Drug
Intervention Name(s)
TZP-101
Intervention Description
600 micrograms/kg IV 2ml/minute for 30 minutes
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
time to tolerance of first solid food
Time Frame
7 days post administration of last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Office of Dr. Phillip Fleshner
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of Miami Clinic
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Univ. of Maryland, R.A. Cowley Shock Trauma Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Baystate Medical Center/Baystate Health
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Michigan State/Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Mid Dakota Clinic, PC
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
St. John's Hospital
City
Bangalore
State/Province
Karnataka
Country
India
Facility Name
Stanley Medical College
City
Chennai
ZIP/Postal Code
600001
Country
India
Facility Name
Amrita Institute of Medical Sciences
City
Cochin
ZIP/Postal Code
682026
Country
India
Facility Name
Lakeshore Hospital
City
Cochin
ZIP/Postal Code
682304
Country
India
Facility Name
Asian Institute of Gastroenterology
City
Hyderabad
ZIP/Postal Code
500082
Country
India
Facility Name
Nizams Institute of Medical Science
City
Hyderabad
ZIP/Postal Code
500083
Country
India
Facility Name
Mediciti Hospitals
City
Hyderabad
ZIP/Postal Code
50063
Country
India
Facility Name
Sanjay Gandhi Post-Graduate Institute of Medical Sciences
City
Lucknow
ZIP/Postal Code
226014
Country
India
Facility Name
Spitalul Urg. SF. Pantelimon
City
Bucharest
ZIP/Postal Code
021659 RO
Country
Romania
Facility Name
Spitalul Universitar Elias
City
Bucharest
Country
Romania
Facility Name
Clinica de Chirugie General IV, Spitalul Universitar
City
Bucuresti
ZIP/Postal Code
00000 RO
Country
Romania
Facility Name
Clinica de Chirugie Generala I, Spitalul Universitar
City
Bucuresti
ZIP/Postal Code
00000 RO
Country
Romania
Facility Name
Clinica de Chirugie Generala III, Spitalul Universitar
City
Bucuresti
ZIP/Postal Code
00000 RO
Country
Romania
Facility Name
Institul Clinic Fundeni
City
Bucuresti
ZIP/Postal Code
00000 RO
Country
Romania
Facility Name
Spitalul Clinic Colentina
City
Bucuresti
ZIP/Postal Code
00000 RO
Country
Romania
Facility Name
Spitalul Clinic Coltea
City
Bucuresti
ZIP/Postal Code
00000 RO
Country
Romania
Facility Name
Spitalul Clinic de Urgenta Floreasca
City
Bucuresti
ZIP/Postal Code
00000 RO
Country
Romania

12. IPD Sharing Statement

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

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