Post-operative ileus in subjects who have undergone partial bowel resection. MedDRA version: 14.0 Level: PT Classification code 10054048 Term: Postoperative ileus System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Product Name: TZP-101/Ulimorelin
Product Code: TZP-101
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ulimorelin hydrocholoride monohydrate
Current Sponsor code: TZP-1
Sponsors
Norgine Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is 18 to 80 years of age, inclusive 2. Patient is scheduled to undergo open bowel resection 3. Female patients must be postmenopausal (for at least 1 year and confirmed by serum follicle-stimulating hormone [FSH]), surgically sterile, practicing true sexual abstinence, OR must be using adequate contraception (in the opinion of the investigator) for the duration of the study, including the follow-up period (e.g. contraceptive implants, injectables, oral contraceptives, some intrauterine devices [IUD], and/or barrier method (condom or occlusive cap) with spermicidal foam/gel/film/cream/suppository) 4. Hormonal and IUD methods of contraception must be established for a period of 3 months prior to dosing and, if changed, alternative methods should be used as directed by the investigator throughout the duration of the study 5. Females of childbearing potential must have a negative pregnancy test at screening and admission After surgery and prior to administration of the first dose of study drug, the following eligibility criteria must be assessed: 6. Patient underwent open bowel resection 7. Patient has given written informed consent 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 115 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 95
Exclusion criteria
Exclusion criteria: 1. Patient weighs more than 200kg (441 pounds) 2. Patient is classified as American Society of Anesthesiologists (ASA) Class 4, 5, or 6 3. Patient has complete bowel obstruction 4. Patient is scheduled to receive a low rectal or anal anastomosis (e.g. proctectomy or ileoanal anastomosis) (low rectal is defined as below the anterior peritoneal reflection - typically 9-10cm from the anal verge) 5. Patient is scheduled for laparoscopic or laparoscopic hand-assisted procedure 6. Patient’s surgical procedure is considered to be an emergency procedure 7. Patient has significant impairment of liver or renal function (alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) 2.5 times the upper limit of normal; creatinine clearance <30mL/minute (min), estimated using serum creatinine with the formula [(140 - age in years) × weight in kg]/[(72 × serum creatinine in mg/dl) × 0.85 for female patients] 8. Patient is anticipated to require prolonged post-operative ventilation 9. Patient has a psychiatric disorder or cognitive impairment that, in the opinion of the Investigator, would interfere with participation in the study 10. Patient has participated in an investigational drug study 30 days prior to the study initiation 11. Patient has a positive laboratory test result for controlled substances (other than for those prescribed by a medical professional and/or accounted for by concomitant medications) at screening 12. Patient is known to have Hepatitis B or Hepatitis C infection currently associated with clinically significant symptoms or abnormal liver function 13. Patient has a recent, adult history of clinically significant hypersensitivity reaction(s) to any drug, in the opinion of the Investigator 14. Patient is pregnant (confirmed by serum pregnancy test) or is breastfeeding 15. Patient has known history of drug or alcohol abuse within the previous year After surgery and prior to administration of the first dose of study drug, the following eligibility criteria must be assessed: 16. Patient received a low rectal or an anal anastomosis (e.g. proctectomy or ileoanal anastomosis) (low rectal is defined as below the anterior peritoneal reflection - typically 9-10cm from the anal verge) 17. Patient underwent a laparoscopic procedure (including a hand-assisted laparoscopic procedure). 18. Patient is classified as American Society of Anesthesiologists (ASA) Class 4, 5, or 6 19. Patients has received ulimorelin previously
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Safety analyses will be presented for the ITT and Safety Populations.;Timepoint(s) of evaluation of this end point: From screening visit to follow up visit. ;Secondary Objective: No secondary objectives.;Main Objective: To evaluate the safety of TZP-101 in comparison with placebo when administered postoperatively in patients who have undergone partial bowel resection. The study aims to increase the number of patients administered ulimorelin in the safety database to approximately 1000 patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Quality of life (QoL) endpoint analyses will be presented for the ITT population. ;Timepoint(s) of evaluation of this end point: Admission, dosing days 1 – 7 inclusive, 24 hours after final dose and 32 days after last dose. | — |
Countries
Czech Republic, Hungary, Lithuania, Russian Federation, Serbia
Contacts
Public ContactDr. Monica Shaw
Norgine Ltd
Outcome results
None listed