A Study to Evaluate the Safety of TZP-101 (IV Ulimorelin) Administered Post-Operatively in Patients Who Have Undergone Partial Bowel Resection

Postoperative Ileus Clinical Trial

Official title:

A Multicentre, Randomised, Double-blind, Placebo-Controlled Study to Evaluate the Safety of TZP-101 (IV Ulimorelin) Administered Post-Operatively in Patients Who Have Undergone Partial Bowel Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01710982
• Other study ID #: NPJ5004-04/2011 (SDS)
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2012
• Last updated: October 17, 2012
• Start date: February 2012
• Est. completion date: April 2012

Study information

• Verified date: September 2012
• Source: Norgine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Medicines Agency
• Study type: Interventional

Clinical Trial Summary

A study to evaluate the safety of TZP-101 in comparison with placebo when administered post-operatively in patients who have undergone partial bowel resection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patient is 18 to 80 years of age, inclusive.

• Patient is scheduled to undergo open bowel resection.

• Female patients must be postmenopausal (for at least 1 year), 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).

• 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

After surgery and prior to administration of the first dose of study drug, the following eligibility criteria must be assessed:

• Patient underwent open bowel resection.

• Patient has given written informed consent

Exclusion Criteria:

• Patient weighs more than 200kg (441 pounds).

• Patient is classified as American Society of Anesthesiologists (ASA) Class 4, 5, or 6

• Patient has complete bowel obstruction.

• 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).

• Patient is scheduled for laparoscopic or laparoscopic hand-assisted procedure.

• Patient's surgical procedure is considered to be an emergency procedure.

• 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].

• Patient is anticipated to require prolonged post-operative ventilation.

• Patient has a psychiatric disorder or cognitive impairment that, in the opinion of the Investigator, would interfere with participation in the study.

• Patient has participated in an investigational drug study 30 days prior to the study initiation.

• 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.

• Patient is known to have Hepatitis B or Hepatitis C infection currently associated with clinically significant symptoms or abnormal liver function.

• Patient has a recent, adult history of clinically significant hypersensitivity reaction(s) to any drug, in the opinion of the Investigator.

• Patient is pregnant (confirmed by pregnancy test) or is breastfeeding.

• 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:

• 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).

• Patient underwent a laparoscopic procedure (including a hand-assisted laparoscopic procedure).

• Patient is classified as American Society of Anesthesiologists (ASA) Class 4, 5, or 6.

• Patients has received ulimorelin previously

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postoperative Ileus

Intervention

Drug:
• TZP-101

Other:
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Norgine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability	To evaluate the safety of TZP-101 in comparison with placebo when administered post-operatively in patients who have undergone partial bowel resection.	32 days post-dosing	No