NL-OMON39494已完成4 期
Clinical evaluation of the efficacy of methylnaltrexone in resolving constipation induced by different opioid subtypes combined with laboratory analysis of immunomodulatory and antiangiogenic effects of methylnaltrexone - Methylnaltrexone for opioid induced constipation
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 195
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age >= 18 years
- •2. Receiving supportive care
- •3. Life expectancy >= 2 weeks
- •4. Able to give informed consent
- •5. Receiving opioid treatment with either morphine sulphate, oxycodone or fentanyl
- •6. Opioid treatment, both
- •a) On a regular schedule (not just as needed or rescue doses) for the control of pain or dyspnea for at least 2 weeks before the first dose of methylnaltrexone, and
- •b) On a stable opioid regimen for at least 3 days before the first dose of methylnaltrexone. This is defined as no dose reduction of >= 50%, dose increases are permitted.
- •7. If a subject uses a combination of short- and long-acting (including continuous administration) opioids, the short-acting opioid should preferably be of the same type as the long-acting opioid. If the subject uses a different type of short-acting opioid than the long-acting opioid, the subject is allowed to enter the study if he/she has used this short-acting opioid <= 2 times a day in the past three days.
- •8. Has diagnosis of constipation, defined as either
- •a) < 3 bowel movements during the previous week by history and no clinically notable laxation* in the 24 hours before the first dose of methylnaltrexone, or
- •b) No clinically notable laxation* in the 48 hours before the first dose of methylnaltrexone.
- •9. Constipation is defined as opioid induced, determined by investigator
- •10. On stable laxative regimen for >= 3 days before the first dose of methylnaltrexone. This is defined as at least one type of laxative in an adequate dosing regimen, (e.g. macrogol 2 packets daily, magnesium(hydr)oxide 500 mg three times daily, bisacodyl 10 mg daily or sennoside A+B 10 ml daily) or at least two types of laxatives in a suboptimal dose with patient characteristics hampering optimal treatment.
- •11. If the subject is a woman with presumed child bearing potential; negative urine pregnancy test at screening
- •12. Surgically sterile or agrees to use a medically acceptable method of birth control or practice sexual abstinence for the duration of the methylnaltrexone treatment and the following 15 days. ~;* including laxation after rescue laxative or enema
- •~ not necessary for postmenopausal women
排除标准
- •1. Previous treatment with methylnaltrexone while using the same opioid subtype
- •2. Known or suspected mechanical gastrointestinal obstruction
- •3. Presence of an other cause of bowel dysfunction that is considered to be a major contribution to the constipation according to investigator
- •4. Presence of a peritoneal catheter for intraperitoneal chemotherapy or dialysis
- •5. Clinically relevant active diverticular disease
- •6. History of bowel surgery within 10 days before first dose of methylnaltrexone
- •7. Fecal ostomy, except for patients who*s defecation pattern was comparable to patients without a fecal ostomy before start of this constipation episode.
- •8. Use of vinca alkaloids within previous 4 months
- •9. Body weight <38 kg
- •10. Renal failure defined as EGFR <30 ml/min per 1.73m2 or requires dialysis.
- •11. Known or suspected allergy to methylnaltrexone or similar compounds (e.g. naltrexone or naloxone)
- •12. Participation in a study with investigational products within 30 days before first dose of methylnaltrexone.
- •13. Pregnant or nursing
- •14. Clinically important abnormalities that may interfere with participation or compliance to the study, determined by investigator ;Additional exclusion criteria for the immunologic and angiogenic analysis part of the study:
- •15. Chemotherapy or treatment with tyrosine kinase inhibitor during 4 weeks before inclusion or treatment scheduled during participation in this study.
- •16. Treatment with high dose corticosteroids during 2 weeks before inclusion in this study. This is defined as the equivalent of 30 mg of prednisone per day for >= 2 consecutive days.
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