Estudio de extensión abierto para evaluar la seguridad de una dosis fija de metilnaltrexona subcutánea en sujetos con enfermedad avanzada y estreñimiento inducido por opiáceosOpen-Label Extension Study to Assess the Safety of a Fixed Dose of Subcutaneous Methylnaltrexone in Subjects With Advanced Illness and Opioid-Induced Constipatio
- Conditions
- Estreñimiento inducido por opiáceosOpioid-induced constipationMedDRA version: 9.1Level: LLTClassification code 10010774Term: Constipation
- Registration Number
- EUCTR2007-006107-20-ES
- Lead Sponsor
- Wyeth Research Division of Wyeth Pharmaceuticals Inc., Global Medical Affairs
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 215
1. Has completed study 3200K1-4000-WW, including 2 weeks of therapy and completion of all postbaseline efficacy, safety, and health outcomes assessments.
2. If not surgically sterile, must agree to use a medically acceptable method of birth control or practice sexual abstinence for the duration of the study and for 15 days after the last dose of methylnaltrexone (unless female and postmenopausal, ie, > 12 months since the last menstrual period).
3. Is receiving opioids on a regular schedule, not just PRN or rescue doses, for the control of pain.
4. Has stable vital signs as determined by the investigator.
5. Has an anticipated continued need for treatment of OIC for the duration of participation in the study.
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
1. Is participating in any other studies involving investigational products.
2. Has a known or suspected mechanical gastrointestinal obstruction.
3. Has clinically important active diverticular disease as determined by the investigator.
4. Has evidence of fecal impaction by physical examination or x-ray examination.
5. Has physical evidence of peritonitis.
6. Has a fecal ostomy.
7. Has known or suspected allergies to methylnaltrexone or other similar compounds (ie, naltrexone, naloxone).
8. Is pregnant and/or nursing.
9. Has any other clinically important abnormalities such that participation would put the subject at undue risk relative to the potential benefit of therapy as determined by the investigator.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of the study is to obtain additional safety data on SC methylnaltrexone administered as needed (PRN; but not more than every 24 hours) to subjects with advanced illness in a realistic end-of-life health care situation.;Secondary Objective: ;Primary end point(s): Safety evaluation will include the collection of adverse events and concomitant medications, vital signs, physical examination, laboratory assessments and calculation of the GFR.<br>Efficacy evaluation: date and time of bowel movements will be collected.<br>
- Secondary Outcome Measures
Name Time Method