E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Post Operative Ileus (POI) in subjects undergoing major open abdominal surgery |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054048 |
E.1.2 | Term | Postoperative ileus |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate safety and efficacy of different doses of TZP-101 for the management of POI in subjects undergoing major open abdominal surgery |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
efficacy - Time to recovery of gastrointestinal function as defined by the time to first bowel movement |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 14 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 14 |
E.8.9.2 | In all countries concerned by the trial days | 0 |