Open-Label Extension Study to Assess the Safety of a Fixed Dose of Subcutaneous Methylnaltrexone in Subjects With Advanced Illness and Opioid-Induced Constipation

Salix Pharmaceuticals Inc0 个研究点目标入组 168 人开始时间: 2008年7月28日最近更新: 2012年12月10日

研究概览

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•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 254
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 254

•1. Is participating in any other studies involving investigational products.
•2. Has a known or suspected mechanical gastrointestinal obstruction; or a known/suspected lesion of the gastrointestinal tract that, in the opinion of the investigator, might be associated with an increased risk of gastrointestinal perforation.
•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.

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