EUCTR2007-006107-20-ES进行中（未招募）不适用
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 Constipation
Wyeth Research Division of Wyeth Pharmaceuticals Inc., Global Medical Affairs0 个研究点目标入组 215 人开始时间: 2010年3月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 215
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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