Study of Methylnaltrexone in Opioid-Induced Constipation Patients
- Registration Number
- NCT02574819
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 198
- A life expectancy of 3 month or more
- Qualifying patients received opioids for analgesia for 1 week or more and a stable regimen of opioids and laxatives for 3 or more days before study entry
- Patients had opioid-induced constipation with either fewer than three laxation during the preceding week and no clinically meaningful laxation (as determined by the in investigator ) within 24h before the first study dose or no clinically meaningful laxation within 48h before the first study dose
- During the two-week trail , patients would keep their life habits (dietary fiber , fluid intake and physical activity)
- Patients volunteered for the trail
- Women of childbearing potential had negative pregnancy tests. Both male and female patients need to take effective contraceptives to avoid pregnancy.
- Constipation that was not primarily caused by opioids ( as determined by the investigator)
- Mechanical gastrointestinal obstruction, an indwelling peritoneal catheter, clinically active diverticular disease , fecal impaction , acute surgical abdomen , and fecal ostomy
- Patients had the surgery plan which would effect the results of pain assessment
- Patients had hypersensitivity to methylnaltrexone , naltrexone or naloxone or if any investigational drug or experimental product
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo administered every other day for 2 weeks. Drug Methylnaltrexone (MNTX) Methylnaltrexone (MNTX) nearly 0.15mg/kg administered every other day for 2 weeks.
- Primary Outcome Measures
Name Time Method The proportion of subjects who had the Rescue-free laxation response within 4 hours of the initial dose up to 4 hours 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.
- Secondary Outcome Measures
Name Time Method The proportion of subjects who had Rescue-free laxation response within 4 hours after each doses from the second dose to the last dose up to 12 days 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 up to 8 days Record the frequency of laxation. After 1-4 dose, within 4 hours of every dose, record the dose number when bowel movement happened
The proportion of subjects who had Rescue-free laxation response within 4-24h after each dose up to 14 days The proportion of subjects who had ≥3 laxation responses per week up to 2 weeks
Trial Locations
- Locations (12)
Henan Provincial Cancer Hospital
🇨🇳Zhengzhou, Henan, China
The Affiliated Hospital of Xuzhou Medical College
🇨🇳Xuzhou, Jiangsu, China
Xin Hua Hospital affiliated to Shanghai Jiao Tong University School of Medicine Chongming Branch
🇨🇳Shanghai, Shanghai, China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Tangdu Hospital
🇨🇳Xian, Shanxi, China
Jiangxi Cancer Hospital
🇨🇳Nanchang, Jiangxi, China
The Second Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Fujian Provincial cancer Hospital
🇨🇳Fuzhou, Fujian, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hebei, China
Linyi Cancer Hospital
🇨🇳Linyi, Shandong, China
Tumor Hospital of Yunnan Province The Third Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China