post-operative ileus in subjects who have undergone partial bowel resection MedDRA version: 12.1 Level: LLT Classification code 10054048 Term: Postoperative ileus
Conditions
Interventions
Product Name: TZP-101 (Ulimorelin) concentrate for solution for infusion
Product Code: TZP-101
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: TZP-101 hydrochloride mon
Sponsors
Tranzyme, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subject is 18 to 80 years of age, inclusive. • Subject is scheduled to undergo open bowel resection with colonic anastomosis. (See Section 11.1 for a list of examples of included and excluded bowel resection surgeries.) • Subject is scheduled to receive post-operative pain management with parenteral opioids (eg, administered IV or intramuscular), but not via thoracic epidural. • Subject is scheduled for the following Enhanced Recovery After Surgery (ERAS) measures: o Nasogastric (NG) tube removed at the end of surgery/anesthesia. o Liquids offered on post-operative day 1 (dosing day 2). o Solid food offered on post-operative day 2 (dosing day 3). o Ambulation encouraged on post-operative day 1 (dosing day 2). • Female subjects 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 (eg, contraceptive implants, injectables, oral contraceptives, some intrauterine devices [IUD], and/or barrier method (condom or occlusive cap) with spermicidal foam/gel/film/cream/suppository). • 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. • Females of childbearing potential must have a negative pregnancy test at screening and admission (human chorionic gonadotropin [beta-hCG]). After surgery and prior to administration of the first dose of study drug, the following eligibility criteria must be assessed: Inclusion: • Subject underwent open bowel resection with colonic anastomosis 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: • Subject weighs more than 200kg (441 pounds). • Subject is classified as American Society of Anesthesiologists (ASA) Class 4, 5, or 6 (See Section 11.2). • Subject has complete bowel obstruction. • Subject is scheduled to receive total colectomy. • Subject is scheduled to receive a low rectal or anal anastomosis (eg, proctectomy, ileoanal anastomosis). • Subject is scheduled to receive a stoma (eg, ileostomy, jejunostomy, colostomy). • Subject is scheduled for laparoscopic or laparoscopic hand-assisted procedure. • Subject is scheduled to receive prophylactic anti-emetics post surgery; however subjects may receive intraoperative anti-emetics as part of the anesthesia protocol. • Subject is scheduled to receive a thoracic epidural for anesthesia or analgesia. • Subject’s surgical procedure is considered to be an emergency procedure. • Subject is scheduled to receive ENTEREG®/alvimopam or any other peripheral opioid antagonist such as RELISTOR®/methylnaltrexone bromide. • Subject 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 subjects]. • Subject is anticipated to require prolonged post-operative ventilation. • Subject has a psychiatric disorder or cognitive impairment that, in the opinion of the Investigator, would interfere with participation in the study. • Subject has participated in an investigational study 30 days prior to the study initiation. • Subject 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. • Subject is known to have Hepatitis B or Hepatitis C infection currently associated with clinically significant symptoms or abnormal liver function. • Subject has a recent, adult history of clinically significant hypersensitivity reaction(s) to any drug, in the opinion of the Investigator. • Subject is pregnant (confirmed by serum pregnancy test) or is breastfeeding. • Subject 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: Exclusion: • Subject has complete bowel obstruction. • Subject received a total colectomy. • Subject received a low rectal or an anal anastomosis (eg proctectomy or ileoanal anastomosis). • Subject received a stoma (eg, jejunostomy, ileostomy, colostomy). • Subject underwent a laparoscopic procedure (including a hand-assisted laparoscopic procedure). • Subject received a thoracic epidural for anesthesia or analgesia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of 2 doses of IV ulimorelin in comparison to placebo administered post-operatively to accelerate recovery of GI motility in subjects who have undergone partial bowel resection, thereby reducing the duration of post-operative ileus (POI);Secondary Objective: No secondary objectives;Primary end point(s): The primary endpoint is the time to recovery of GI function as defined by the time from the end of surgery to GI2, the later of first BM and tolerance of solid food (ie, having finished a meal that required chewing and having experienced no significant nausea/vomiting for 4hr after the meal). | — |
Countries
Hungary, Italy, United Kingdom
Outcome results
None listed