A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Intravenous Methylnaltrexone (MOA-728) for the Treatment of Postoperative Ileus After Ventral Hernia Repair

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-001298-27-HU
• Date of registration: 15/06/2007
• Prospective Registration: Yes
• Primary sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc.
• Public title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Intravenous Methylnaltrexone (MOA-728) for the Treatment of Postoperative Ileus After Ventral Hernia Repair
• Scientific title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Intravenous Methylnaltrexone (MOA-728) for the Treatment of Postoperative Ileus After Ventral Hernia Repair
• Date of first enrolment: 07/08/2007
• Target sample size: 495
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-001298-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: Single blind: Double blind: yes Parallel group: yes Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: yes Other:

Countries of recruitment

Belgium, Germany, Hungary, Italy, Netherlands

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subjects must sign and date an ICF.
2. Male and female subjects ³18 years of age.
3. Subjects must meet the American Society of Anesthesiologists (ASA) physical status I, II, or III.
4. Subjects must be scheduled for repair of a large (estimated to be at least ³10 cm) ventral hernia with or
without mesh prosthesis via laparotomy or laparoscopy with general anesthesia.
5. Subjects must have an anticipated length of hospital stay of at least 3 days.
6. Subjects with a history of inflammatory bowel disease are eligible as long as the disease is not currently active and all other criteria are met.
7. Women of childbearing potential must have a negative serum pregnancy test at the screening visit and a negative urine or serum pregnancy test before surgery and must agree and commit to the use of a reliable method of birth control for the duration of the study and for 15 days after the last dose of test article. Appropriate forms of birth control are abstinence; oral, implantable, or injectable contraceptives; spermicide in conjunction with a barrier such as a condom or diaphragm; and intrauterine device. A woman of childbearing potential is one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives. Men who are sexually active must agree and commit to the use of a medically acceptable form of contraception during the study and for 15 days after the last dose of test article.
8. Body weight within the range of 40 to 150 kg (88 to 330 lb).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Subjects with known hypersensitivity to methylnaltrexone, naltrexone, or naloxone.
2. Subjects who received any investigational new drug or procedure (experimental) within 30 days before randomization.
3. Subjects with a recent history of treatment with vinca alkaloids (£6 months before randomization).
4. Subjects undergoing operations that include a planned bowel resection or colostomy.
5. Subjects with clinically important laboratory abnormalities or a significant medical and/or psychiatric history and comorbidities that would make participation in an investigational study inappropriate or make them highrisk for any surgical procedures.
6. Subjects whose medical history requires use of postoperative nonsteroidal anti-inflammatory drugs (NSAIDs).
7. Subjects taking tricyclic antidepressants.
8. Subjects with corrected QT (QTc) interval greater than 500 ms based on the 12-lead screening
electrocardiogram (ECG).
9. Subjects with a history of alcohol abuse or prescription or nonprescription drug abuse within the past 2 years.
10. Subjects with a history of chronic constipation.
11. Known history of chronic active hepatitis B, hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection.
12. Women who are lactating.
13. Subjects with a calculated creatinine clearance (Cockcroft-Gault GFR) =50 mL/min.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Post operative ileus (POI). This study will examine the effect of IV MOA-728 versus placebo in shortening the time to return of bowel function in subjects receiving opioid analgesia administered via PCA, who have undergone repair of large (³10 cm, measured from edge to edge in its greatest dimension) ventral hernias with or without a mesh prosthesis.

Intervention(s)

Product Name: MNTX/MOA-728 Lyophilized Powder for Solution for Infusion 12mg/vial
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Methylnaltrexone Bromide
CAS Number: 73232-52-7
Current Sponsor code: 0151,MNTX/MOA, 3031 MNTX
Other descriptive name: Naltrexone Methobromide, N-methylnaltrexone bromide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Product Name: MNTX/MOA-728 Lyophilized Powder for Solution for Infusion 12mg/vial
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Methylnaltrexone Bromide
CAS Number: 73232-52-7
Current Sponsor code: 0151,MNTX/MOA, 3031 MNTX
Other descriptive name: Naltrexone Methobromide, N-methylnaltrexone bromide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 24-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Main Objective: The primary objective of this study is to assess the efficacy of IV MOA-728 in subjects who have undergone repair of large (³10 cm) ventral hernias, with or without a mesh prosthesis via laparotomy or laparoscopy.

Primary end point(s): The time between the end of surgery and the first bowel movement.

Secondary Objective: The secondary objectives are 1) to assess the safety of IV MOA-728 administered approximately every 6 hours in these postsurgical subjects and 2) to examine clinically meaningful events for nausea or retching/vomiting at 24 hours after the first dose as evaluated by the Opioid Related Symptom Distress Scale (SDS) instrument.

Secondary ID(s)

3200L-301-WW