Study to Evaluate the Safety of Post-Operative TZP-101 (IV Ulimorelin) After Partial Bowel Resection

NCT01710982 | Completed Phase 3

• 1 other identifier: NPJ5004-04/2011 (SDS)
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Postoperative Ileus

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

TZP-101

ACTIVE COMPARATOR

TZP-101

Drug: TZP-101

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

TZP-101 DRUG

Also known as: Ulimorelin HCl monohydrate (ulimorelin·HCl·H2O)

TZP-101

Placebo OTHER

Also known as: Placebo (5% dextrose solution in Water for Injection)

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Norgine: lead

MeSH Terms

Interventions

ulimorelin; Water; Injections

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Sandy Eisen, MD

  Norgine Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2012
• First Posted: October 19, 2012
• Study Start: February 1, 2012
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: September 19, 2024

Record last verified: 2024-09