Safety and Efficacy of IV Infusion of TZP-101 for POI After Major Open Abdominal Surgery (NCT00617552) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of IV Infusion of TZP-101 for POI After Major Open Abdominal Surgery
United States267 participantsStarted 2007-07
Plain-language 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).
Who can participate
Age range18 Years – 80 Years
SexALL
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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 …
What they're measuring
1
Time to recovery of gastrointestinal function as defined by the time to first bowel movement.
Timeframe: 7 days of dosing plus 7 days after administration of last dose