JPRN-jRCTs031200397进行中（未招募）2 期
Effects of opioid and naldemedine combined therapy on opioid-induced constipation for cancer patients with cancer pain: Randomized placebo-controlled double-blind trial
Jun Hamano0 个研究点目标入组 100 人开始时间: 2021年3月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Cancer patients who are starting regular oral use of strong opioids (morphine, oxycodone,
- •hydromorphone) for the first time for cancer pain
- •2) Age 20 years or older (at the time of obtaining consent)
- •3) Patients who are able to take oral medications, food, and beverages
- •4) Patients who are considered capable of self-recording in the patient diary (proxy recording in the patient
- •diary is acceptable if the patient is capable of self-assessment).
- •5) Patients who are not expected to have a rapid change in their cancer condition during the study period.
- •6) Patients who have received sufficient explanation and written consent of their own free will to participate
- •in this study.
排除标准
- •1) Patients with gastrointestinal obstruction or suspected gastrointestinal obstruction, or patients with
- •a history of gastrointestinal obstruction and a high risk of recurrence
- •2) Patients who have undergone surgery, radiotherapy, or procedures affecting gastrointestinal function
- •(e.g., nerve block) within 14 days prior to the date of enrollment, or who are scheduled to undergo such
- •procedures during the study period.
- •3) Patients with medically significant cardiovascular, respiratory, hepatic, or renal dysfunction based on
- •history, clinical laboratory values, electrocardiogram, or physical examination, who are judged inappropriate to participate in the study.
- •4) Patients who have received or are currently receiving naldemedine medication
- •5) Patients who have had severe diarrhea (more than 7 times a day) or who have had a stool extraction for constipation within the past 7 days
- •6) Patients who have used opioid patches or injectable opioids in the past 7 days.
- •7) Patients who have received cancer drug therapy that is certain to affect defecation within 14 days prior to the initial enrollment date, or who are scheduled to receive such therapy within the study period. Cancer
- •drug therapy that is certain to affect defecation will be defined as follows.
- •1.Initial administration of a therapeutic regimen containing irinotecan (CPT-11)
- •2.Other cancer drug therapy that is considered certain to affect defecation.
- •However, the following cases may be considered as not affecting defecation
- •a) Chemotherapy with the same regimen as the previous course or chemotherapy with the same drug and
- •dose, and there was no moderate or greater constipation or diarrhea (CTCAE v5.0 Grade 2 or higher)
- •during the previous course or previous chemotherapy.
- •b) Patients who have received oral anticancer agents (e.g. TS-1) daily and have not had moderate or severe constipation or diarrhea (CTCAE v5.0 Grade 2 or higher) for at least 1 week from the start of oral
- •chemotherapy to the start of study drug.
- •8) Pregnant or lactating patients
- •9) Patients with suspected hypersensitivity to opioid receptor antagonists such as naldemedine, naltrexone, methylnaltrexone, and naloxone.
- •10) Other patients who are judged by the principal investigator or sub-investigator to be inappropriate for
- •participation in the study based on concomitant therapy or medical findings.
研究者
相似试验
进行中（未招募）
1 期
aldemedine OIBDOpioid induced bowel dysfunctionCTIS2023-507744-36-00Aalborg University Hospital20
已完成
不适用
Effect of combination therapy with amlodipine and atorvastatin on blood pressure varaiability, vascular function and renal function in hypertensive patients with chronic kidney diseaseHypertension with chronic kidney disease (CKD stage 1-4)JPRN-UMIN000009045Yokohama city university hospital50
已完成
不适用
The effects of drugs on the pain after LithotripsyKidney Stone.Calculus of kidneyIRCT2016051427893N1Vice Chancellor for research of Esfarayen University of Medical Sciences75
进行中（未招募）
不适用
A Phase 1/2 Study of Lenalidomide in combination with Bendamustine (LEBEN) in relapsed and primary refractory Hodgkin Lymphomarelapsed and primary refractory Hodgkin LymphomaMedDRA version: 14.1Level: LLTClassification code 10020328Term: Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-002810-35-ITISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE
已完成
3 期
Superiority comparative test of conventional treatment vs naldemedine for prevention of opioid-induced constipation in cancer patients: Investigator initiated, single center, 2 arm, open label, randomized controlled trialsCancer patients prescribing opioidsJPRN-UMIN000031891Yokohama city university hospotal100