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

Sponsored by:	Tranzyme, Inc.
Information provided by:	Tranzyme, Inc.
ClinicalTrials.gov Identifier:	NCT00617552

Purpose

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	Intervention	Phase
Postoperative Ileus	Drug: 5% dextrose in water Drug: TZP-101	Phase II

MedlinePlus related topics: Surgery

Drug Information available for: Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Tranzyme, Inc.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

time to tolerance of first solid food [ Time Frame: 7 days post administration of last dose ] [ Designated as safety issue: No ]

Enrollment:	267
Study Start Date:	July 2007
Study Completion Date:	August 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: 5% dextrose in water 60 ml IV infusion over 30 minutes
2: Experimental	Drug: TZP-101 20 micrograms/kg IV 2ml/minute for 30 minutes
3: Experimental	Drug: TZP-101 40 micrograms/kg IV 2 ml/minute for 30 minutes
4: Experimental	Drug: TZP-101 80 micrograms/kg IV 2ml/minute for 30 minutes
5: Experimental	Drug: TZP-101 160 micrograms/kg IV 2ml/minute over 30 minutes
6: Experimental	Drug: TZP-101 320 micrograms/kg IV 2ml/minute for 30 minutes
7: Experimental	Drug: TZP-101 480 micrograms/kg IV 2ml/minute over 30 minutes
8: Experimental	Drug: TZP-101 600 micrograms/kg IV 2ml/minute for 30 minutes

Detailed Description:

Subjects will be randomized according to an adaptive randomization procedure.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617552

Show 27 Study Locations

Sponsors and Collaborators

Tranzyme, Inc.

More Information

No publications provided

Responsible Party:	Tranzyme, Inc. ( Gordana Kosutic, MD Vice President Clinical & Regulatory Affairs )
Study ID Numbers:	TZP-101-CL-P005
Study First Received:	February 6, 2008
Last Updated:	November 3, 2008
ClinicalTrials.gov Identifier:	NCT00617552 History of Changes
Health Authority:	United States: Food and Drug Administration; Romania: National Medicines Agency; Lithuania: State Medicine Control Agency - Ministry of Health; India: Drugs Controller General of India

Keywords provided by Tranzyme, Inc.:

postoperative ileus
POI
major open abdominal surgery

Study placed in the following topic categories:

Ileus

ClinicalTrials.gov processed this record on May 07, 2009