A Phase 3, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the treatment of Post-Operative Ileus (POI)
- Conditions
- Post Operative ileus (POI) in patients who have had a segmental colectomy via open laparotomy.
- Registration Number
- EUCTR2006-006383-29-FR
- Lead Sponsor
- Progenics Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
1. Male and female subjects > 18 years of age.
2. Patients must meet the American Society of Anesthesiologists (ASA) physical status I, II, or III.
3. 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 and low anterior proctosigmoidectomy. All patients must have a primary anastomosis.
4. Patients with a history of inflammatory bowel disease are eligible as long as the disease is not currently active and all other criteria are met.
5. Negative for history of chronic active hepatitis B, HCV or HIV infection.
6. Patients must sign an ICF.
7. Females of childbearing potential must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test prior to surgery and must use appropriate forms of birth control (oral, implantable or injectable contraceptives; spermicide in conjunction with a barrier such as a condom or diaphragm; intrauterine device or (IUD), throughout the study.
8. Body weight within range of 40 kg 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) 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
Patients will be excluded from the study if the meet any of the following exclusion criteria:
1. Patients who are scheduled for laparoscopic surgery for the segmental colectomy.
2. Patients with known hypersensitivity to methylnaltrexone, naltrexone, or naloxone.
3. Patients who received any investigational new drug (experimental) in the 30 days prior to screening visit.
4. Patients with clinical evidence of radiation enteritis.
5. Patients with recent history of treatment with Vinca alkaloids (< 6 months).
6. Patients with history of ulcerative colitis.
7. Patients undergoing operations resulting in gastrointestinal ostomies.
8. Patients with 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.
9. Patients with stage IV malignancies or ASA status IV are excluded.
10. Patients with a prior history of total colectomy, small bowel obstruction, known or suspected bowel adhesions (other than minor, clinically non-significant adhesions), or endometriosis of the bowel.
11. Patients who are anticipated to use post-operative non-steroidal anti-inflammatories (NSAIDs) prior to the primary endpoint being met.
12. Patients taking tricyclic antidepressants.
13. Patients with QTc interval greater than 500ms based on the 12-lead screening electrocardiogram (ECG).
14. Patients with a history of alcoholic or prescription or non-prescription drug abuse within the past two years.
15. Females who are pregnant or lactating.
16. Patients with calculated creatinine clearance (Cockcroft-Gault GRF) <50ml/min.
Pre-operative Period
Within 24 hours of the planned segmental colectomy, Investigators or designees will review inclusion/exclusion criteria, obtain vital sign measurements including body weight, review concomitant medications, obtain a urine pregnancy test (within 72 hours of dosing) for women of childbearing potential, clinical laboratory tests, and a 12-lead ECG recording. Patients who continue to meet all inclusion/exclusion criteria within 24 hours of surgery will be allowed to continue in the study. Patients who no longer qualify will be discontinued and managed at the discretion of the attending physician.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method