NCT00617552

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
267

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_2

Geographic Reach
3 countries

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 18, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

December 7, 2012

Status Verified

December 1, 2012

Enrollment Period

1 year

First QC Date

February 6, 2008

Last Update Submit

December 5, 2012

Conditions

Postoperative Ileus

Keywords

postoperative ileusPOImajor open abdominal surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • time to tolerance of first solid food

    7 days post administration of last dose

Study Arms (8)

1

PLACEBO COMPARATOR
Drug: 5% dextrose in water

2

EXPERIMENTAL
Drug: TZP-101

3

EXPERIMENTAL
Drug: TZP-101

4

EXPERIMENTAL
Drug: TZP-101

5

EXPERIMENTAL
Drug: TZP-101

6

EXPERIMENTAL
Drug: TZP-101

7

EXPERIMENTAL
Drug: TZP-101

8

EXPERIMENTAL
Drug: TZP-101

Interventions

5% dextrose in waterDRUG

60 ml IV infusion over 30 minutes

Also known as: D5W
1
TZP-101DRUG

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

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Office of Dr. Phillip Fleshner

Los Angeles, California, 90048, United States

Location

University of Miami Clinic

Miami, Florida, 33136, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Univ. of Maryland, R.A. Cowley Shock Trauma Center

Baltimore, Maryland, 21201, United States

Location

Baystate Medical Center/Baystate Health

Springfield, Massachusetts, 01199, United States

Location

Michigan State/Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

Mid Dakota Clinic, PC

Bismarck, North Dakota, 58501, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

St. John's Hospital

Bangalore, Karnataka, India

Location

Stanley Medical College

Chennai, 600001, India

Location

Asian Institute of Gastroenterology

Hyderabad, 500082, India

Location

Nizams Institute of Medical Science

Hyderabad, 500083, India

Location

Mediciti Hospitals

Hyderabad, 50063, India

Location

Amrita Institute of Medical Sciences

Kochi, 682026, India

Location

Lakeshore Hospital

Kochi, 682304, India

Location

Sanjay Gandhi Post-Graduate Institute of Medical Sciences

Lucknow, 226014, India

Location

Clinica de Chirugie General IV, Spitalul Universitar

Bucharest, 00000 RO, Romania

Location

Clinica de Chirugie Generala I, Spitalul Universitar

Bucharest, 00000 RO, Romania

Location

Clinica de Chirugie Generala III, Spitalul Universitar

Bucharest, 00000 RO, Romania

Location

Institul Clinic Fundeni

Bucharest, 00000 RO, Romania

Location

Spitalul Clinic Colentina

Bucharest, 00000 RO, Romania

Location

Spitalul Clinic Coltea

Bucharest, 00000 RO, Romania

Location

Spitalul Clinic de Urgenta Floreasca

Bucharest, 00000 RO, Romania

Location

Spitalul Urg. SF. Pantelimon

Bucharest, 021659 RO, Romania

Location

Spitalul Universitar Elias

Bucharest, Romania

Location

MeSH Terms

Interventions

GlucoseWaterulimorelin

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2008

First Posted

February 18, 2008

Study Start

July 1, 2007

Primary Completion

July 1, 2008

Study Completion

August 1, 2008

Last Updated

December 7, 2012

Record last verified: 2012-12

Locations

IN(8)RO(9)US(10)