A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Intravenous (IV) Methylnaltrexone (MOA-728) for the Treatment of Post Operative Ileus - N/A

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-004273-10-HU
• Date of registration: 21/02/2007
• Prospective Registration: No
• Primary sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc.
• Public title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Intravenous (IV) Methylnaltrexone (MOA-728) for the Treatment of Post Operative Ileus - N/A
• Scientific title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Intravenous (IV) Methylnaltrexone (MOA-728) for the Treatment of Post Operative Ileus - N/A
• Date of first enrolment: 02/02/2007
• Target sample size: 495
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-004273-10
• 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

Czech Republic, Germany, Hungary, Italy

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subjects must sign an ICF.
2. Male and female subjects > 18 years of age.
3. Subjects must meet the American Society of Anesthesiologists (ASA) physical status I, II, or III (see attachment 2).
4. Subjects must be scheduled for a segmental colectomy via open laparotomy with general anesthesia. Acceptable procedures include partial colectomy, colectomy (right or left), transverse colectomy, hemicolectomy (right or left), sigmoidectomy, cecectomy, anterior proctosigmoidectomy, low anterior proctosigmoidectomy and colostomy takedown with re-anastomosis. All subjects must have a primary anastomosis.
5. 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.
6. Negative for history of chronic active hepatitis B, HCV or HIV infection.
7. Women of childbearing potential must have a negative serum pregnancy test result at the screening visit and 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 range of 40 to 150 kg (88 to 330 lbs.)
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 who are scheduled for laparoscopic surgery for the segmental colectomy.
2. Subjects with known hypersensitivity to methylnaltrexone, naltrexone, or naloxone.
3. Subjects who received any investigational new drug or procedures (experimental) in the previous 30 days prior to randomization.
4. Subjects with a recent history of treatment with Vinca alkaloids (< or = to 6 months prior to randomization.
5. Subjects with history of ulcerative colitis.
6. Subjects undergoing operations resulting in gastrointestinal ostomies.
7. Subjects with a clinically significant lab abnormality, a significant medical and/or
psychiatric history and co-morbidities that would make participation in an investigational study inappropriate or make them high-risk for any surgical procedures. Subjects with stage IV malignancies are excluded.
8. Subjects with a prior history of small bowel obstruction, known or suspected bowel
adhesions (other than minor, clinically nonsignificant adhesions), or endometriosis of the bowel.
9. Subjects who require use of post-operative nonsteroidal anti-inflammatory drugs (NSAIDs).
10. Subjects taking tricyclic antidepressants.
11. Subjects with QTc interval greater than 500 ms based on the 12-lead screening
electrocardiogram (ECG).
12. Subjects with a history of alcohol or prescription or non-prescription drug abuse within the past 2 years.
13. Females who are pregnant or lactating.
14. Subjects with calculated creatinine clearance (Cockcroft-Gault GFR) < 50 ml/min

Post-operative Requirements for Continuation and Randomization

1. Subjects must have stable vital signs (clinical judgment of Investigator).
2. Subjects must be receiving, or ordered to receive, IV opioids via patient-controlled
analgesia (PCA) with morphine, hydromorphone or fentanyl, for post-operative pain
relief.
3. No evidence of residual (unresected) clinically active Crohn’s disease.
4. No intra-operative findings or evidence of clinically significant radiation enteritits.
5. Subjects must not have any complications of surgical procedures, intra-operative findings or unanticipated surgical procedures that would make participation in the study inappropriate (clinical judgment of Investigator).
6. NG tube must be removed.


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

Health Condition(s) or Problem(s) studied

Post operative ileus (POI) in patients who have had a segmental colectomy via open laparotomy.

Intervention(s)

Product Name: MNTX/MOA-728 Lyophilized Powder for Solution for Infusion 12 mg/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-728, 3031, MNTX
Other descriptive name: Naltrexone Methobromide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12-
Pharmaceutical form of the placebo: Powder for solution for infusion
Route of administration of the placebo: Intravenous use

Product Name: MNTX/MOA-728 Lyophilized Powder for Solution for Infusion 24 mg/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-728, 3031, MNTX
Other descriptive name: Naltrexone Methobromide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 24-
Pharmaceutical form of the placebo: Powder for solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Secondary Objective: 1) To assess the safety of IV MOA-728 administered every 6 hours in these post-surgical patients
2) To assess the the effects of IV MOA-728 on time to discharge eligibility and time to hospital discharge from end of surgery
3) To examine frequency and bothersomeness of nausea and vomiting as assessed by the Symptom Stress Scale (SDS) instrument.

Main Objective: To test the following hypothesis: in patients who have undergone segmental colectomy, the time between the end of surgery and first bowel movement is significantly shorter in the MOA-728 regimen than the equivalent assesment using a placebo regimen.

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

Secondary ID(s)

3200L2-300-WW

2006-004273-10-DE

N/A