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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00617552

Enrollment

267

Registered

2008-02-18

Start date

2007-07-31

Completion date

2008-08-31

Last updated

2012-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Ileus

Keywords

postoperative ileus, POI, major open abdominal surgery

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.

Interventions

DRUG5% dextrose in water

60 ml IV infusion over 30 minutes

DRUGTZP-101

20 micrograms/kg IV 2ml/minute for 30 minutes

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Time to recovery of gastrointestinal function as defined by the time to first bowel movement.	7 days of dosing plus 7 days after administration of last dose

Secondary

Measure	Time frame
time to tolerance of first solid food	7 days post administration of last dose

Countries

India, Romania, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026