Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00617552
Recruitment Status : Completed
First Posted : February 18, 2008
Last Update Posted : December 7, 2012
Sponsor:
Information provided by (Responsible Party):
Tranzyme, Inc.

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).

Condition or disease Intervention/treatment Phase
Postoperative Ileus Drug: 5% dextrose in water Drug: TZP-101 Phase 2

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 267 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : July 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : August 2008

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 Measures :
  1. time to tolerance of first solid food [ Time Frame: 7 days post administration of last dose ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00617552


Locations
Show Show 27 study locations
Sponsors and Collaborators
Tranzyme, Inc.

Layout table for additonal information
Responsible Party: Tranzyme, Inc.
ClinicalTrials.gov Identifier: NCT00617552    
Other Study ID Numbers: TZP-101-CL-P005
First Posted: February 18, 2008    Key Record Dates
Last Update Posted: December 7, 2012
Last Verified: December 2012
Keywords provided by Tranzyme, Inc.:
postoperative ileus
POI
major open abdominal surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases