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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00617552
• Date of registration: 06/02/2008
• Prospective Registration: No
• Primary sponsor: Tranzyme, Inc.
• Public title: Safety and Efficacy of IV Infusion of TZP-101 for POI After Major Open Abdominal Surgery
• Scientific 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
• Date of first enrolment: July 2007
• Target sample size: 267
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00617552
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

India, Romania, United States

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Postoperative Ileus

Intervention(s)

Drug: TZP-101

Drug: 5% dextrose in water

Primary Outcome(s)

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]

Secondary Outcome(s)

time to tolerance of first solid food [Time Frame: 7 days post administration of last dose]

Secondary ID(s)

TZP-101-CL-P005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors