2023-509462-38-00招募中4 期
Prevention of opioid-induced constipation in patients with advanced cancer.
Amsterdam UMC16 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2024年10月28日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 16
- 主要终点
- The primary endpoint is constipation, defined as the percentage of patients with a score of <30 of the Bowel Function Index, measured on day 14.
研究概览
简要总结
In patients with advanced cancer, starting with opioids for pain: To prove non-inferiority of magnesium hydroxide to macrogol/electrolytes in the prevention of OIC, based on the percentage of patients without constipation (BFI-score <30) after 14 days of treatment.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria: Patients with advanced cancer (≥18 years);
- •Starting with slow release or transdermal opioids for pain;
- •Able to complete a Dutch questionnaire.
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study: Patients with contra-indications for laxatives;
- •Maintenance treatment with laxatives during the last two weeks
- •Severely impaired renal function (serum creatinine >180 umol/l);
- •Diarrhea at the start of the study, defined as the passage of three or more loose or liquid stools per day (or more frequent passage than is normal for the individual).
- •Life expectancy < 1 month
结局指标
主要结局
The primary endpoint is constipation, defined as the percentage of patients with a score of <30 of the Bowel Function Index, measured on day 14.
The primary endpoint is constipation, defined as the percentage of patients with a score of <30 of the Bowel Function Index, measured on day 14.
次要结局
- Change of the Bowel Function Index Score between day 0 and day 14;
- Quality of life;
- Rome IV criteria for opioid-induced constipation as judged by professional care givers;
- Cancer pain score;
- Side effects of laxatives;
- Cost-effectiveness of macrogol/electrolytes compared to magnesium hydroxide;
- Patient satisfaction with laxative.
研究者
Kay Kistemaker
Scientific
Amsterdam UMC
研究点 (16)
Loading locations...
相似试验
Enrolling By Invitation
不适用
Tramadol / Magnesium in Ropivacaine Solution in UG-bilateral TAP Block and Analgesia in Robotic Radical ProstatectomyNCT07289321Aretaieion University Hospital90
招募中
不适用
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold (RMS) System in Subjects With Coronary Artery LesionsMyocardial IschemiaAcute Coronary SyndromeAngina PectorisArteriosclerosisCoronary Artery DiseaseNCT07258290Teleflex1,859
招募中
2 期
Naldemedine OIBD2023-507744-36-00Aalborg University Hospital20
已完成
4 期
A Study Of Opioid Avoidance In Surgery Through Integrating SuzetrigineNCT07257133Mayo Clinic100
招募中
不适用
Use of Preoperative Postbiotic Supplementation in Colorectal Cancer SurgeryNCT07268846AC Camargo Cancer Center164