A Phase II Study of the Preventive Effectiveness and Safety of Lubiprostone in Opioid-Induced Constipation (OIC) Caused by Opioid Analgesics for the Treatment of Cancer Pain

未提供0 个研究点目标入组 37 人开始时间: 2025年1月10日最近更新: 2025年2月25日

试验速览

阶段: 不适用
状态: 招募中
入组人数: 37
主要终点: Percentage of patients diagnosed with opioid-induced constipation (OIC) by ROME IV criteria

暂无简介。

•cancer patients over 18 years of age who are involved with the Palliative Care Team and Palliative Care Unit
•patients who are receiving opioid analgesics (morphine, oxycodone, hydromorphone, tapentadol, fentanyl, tramadol, codeine phosphate) for the first time for cancer pain

•patients with diagnosed or suspected intestinal obstruction
•patients who are unable to take oral intake
•patients with ECOG PS4
•patients who have difficulty in obtaining written consent and completing the questionnaire
•patients with Child-Pugh B or C
•patients with eGFR less than 30 mL/min/1.73 m2
•Patients with a history of allergy or contraindication to Lubiprostone
•patients with diarrhea (Bristol stool scale 6 or 7)
•patients with a history of irritable bowel syndrome

Percentage of patients diagnosed with opioid-induced constipation (OIC) by ROME IV criteria

时间窗: one week after starting the study

Percentage of patients diagnosed with opioid-induced constipation (OIC) by ROME IV criteria

change in frequency of spontaneous defecation(during the first week of the study)
percentage of patients using rescue laxatives(during the study period)
percentage of patients experiencing nausea, vomiting, or diarrhea(during the study period)
other adverse events

发起方

未提供