This is a multicenter, randomized, double-blind , placebo-controlled trail to investigate the safety and efficacy of subcutaneous methylnaltrexone for treating opioid-induced constipation in patients with advanced illness.
Methylnaltrexone is a quaternary derivative of the pure opioid antagonists naltrexone. It is fairly lipid soluble and readily cross the blood-brain barrier. This property provides methylnaltrexone with the potential to block the undesired side-effects of opioid pain medications predominantly mediated by receptors located peripherally while sparing opioid effects mediated at receptors in the central nervous system, most importantly analgesia. This is a multicenter, randomized, double-blind , placebo-controlled trail to investigate the safety and efficacy of subcutaneous methylnaltrexone for treating opioid-induced constipation in patients with advanced illness. The randomization schedule was used to assign patients in a 2:1 ratio to multicenter or an equal volume of placebo administered subcutaneously on alternate days for 2 weeks. The clinical trail was estimated to enroll 180 patients totally.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
198
MNTX nearly 0.15mg/kg administered every other day for 2 weeks. Baseline laxatives and rescue laxative ( enemas/suppositories ) were allowed, but could not be administered within 4 hours of the study drug.
Placebo administered every other day for 2 weeks. Baseline laxatives and rescue laxative ( enemas/suppositories ) were allowed, but could not be administered within 4 hours of the study drug.
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
RECRUITINGFujian Provincial cancer Hospital
Fuzhou, Fujian, China
The proportion of subjects who had the Rescue-free laxation response within 4 hours of the initial dose
Within 4 hours after the initial dose, if clinical significant bowel movement happened, the drug therapeutic effect was confirm. In the meantime, the time of bowel movement and other properties of bowel movement were recorded. The percentage of patients who had rescue-free laxation response is the primary outcome.
Time frame: up to 4 hours
The proportion of subjects who had at least 2 Rescue-free laxation responses within 4 hours after each doses from the first dose to the forth dose
Record the frequency of laxation. After 1-4 dose, within 4 hours of every dose, record the dose number when bowel movement happened
Time frame: up to 8 days
The proportion of subjects who had Rescue-free laxation response within 4 hours after each doses from the second dose to the last dose
Time frame: up to 12 days
The proportion of subjects who had Rescue-free laxation response within 4-24h after each dose
Time frame: up to 14 days
The proportion of subjects who had ≥3 laxation responses per week
Time frame: up to 2 weeks
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Zhongnan Hospital of Wuhan University
Wuhan, Hebei, China
RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
RECRUITINGHenan Provincial Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGThe Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, China
RECRUITINGJiangxi Cancer Hospital
Nanchang, Jiangxi, China
RECRUITINGLinyi Cancer Hospital
Linyi, Shandong, China
RECRUITINGXin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGXin Hua Hospital affiliated to Shanghai Jiao Tong University School of Medicine Chongming Branch
Shanghai, Shanghai Municipality, China
RECRUITING...and 2 more locations