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

NCT00617552 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2012-12-07

No results posted yet for this study

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).

Conditions

  • Postoperative Ileus

Interventions

DRUG

5% dextrose in water

60 ml IV infusion over 30 minutes

DRUG

TZP-101

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

DRUG

TZP-101

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

DRUG

TZP-101

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

DRUG

TZP-101

160 micrograms/kg IV 2ml/minute over 30 minutes

DRUG

TZP-101

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

DRUG

TZP-101

480 micrograms/kg IV 2ml/minute over 30 minutes

DRUG

TZP-101

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

Sponsors & Collaborators

  • Tranzyme, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-07-31
Completion
2008-08-31

Countries

  • United States
  • India
  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00617552 on ClinicalTrials.gov