Post Operative Ileus (POI) in subjects undergoing major open abdominal surgery MedDRA version: 9.1 Level: LLT Classification code 10054048 Term: Postoperative ileus
Conditions
Interventions
Product Code: TZP-101
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: TZP-101 HCl monohydrate
Current Sponsor code: TZP-101
Concentration unit: mg/ml milligram(s)/millilitre
Concentrat
Sponsors
Tranzyme, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - male or female, 18 to 80 years of age, inclusive - if female, postmenopausal for the past 12 months, surgically sterile, (ie tubal ligation, hysterectomy) or using an adequate method of birth control (ie oral contraceptives, double barrier method, IUD cover or sterilized partner) - subject is scheduled to undergo a partial large bowel resection with primary anastomosis - subject's body weight is less than or equals 100 kg - subject is scheduled to receive postoperative pain management with iv 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - a marked baseline prolongation of QT/QTc interval (eg repeated demonstration of a QTc interval >450 men />470 women milliseconds - subjects 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 procedure manual - subject required use of concomitant medication that is known to interact with izoenzyme CYP3A4 - list provided in study procedures manual - subject has complete bowel obstruction - 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 recive 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 and half times 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 disease subject has participated in an investigational study 30 days prior or received TZP-101 90 dyas 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 significany hypersensitivity reaction to any drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate safety and efficacy of different doses of TZP-101 for the management of POI in subjects undergoing major open abdominal surgery;Secondary Objective: no secondary objective;Primary end point(s): efficacy - Time to recovery of gastrointestinal function as defined by the time to first bowel movement | — |
Countries
Lithuania
Outcome results
None listed