Clinical trial NCT02574819: Study of Methylnaltrexone in Opioid-Induced Constipation Patients
Official title: Methylnaltrexone (MNTX) for Treatment of Opioid-induced Constipation in Advanced Illness Patients : a Multicenter, Randomized, Double-blind , Placebo-controlled Trail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Opioid-induced Constipation
Keywords: opioid-induced constipation
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-10-14
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: The proportion of subjects who had the Rescue-free laxation response within 4 hours of the initial dose
timeFrame: up to 4 hours
Secondary outcomes:
measure: 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
timeFrame: up to 8 days
measure: The proportion of subjects who had Rescue-free laxation response within 4 hours after each doses from the second dose to the last dose
timeFrame: up to 12 days
measure: The proportion of subjects who had Rescue-free laxation response within 4-24h after each dose
timeFrame: up to 14 days
measure: The proportion of subjects who had ≥3 laxation responses per week
timeFrame: up to 2 weeks
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
city: Fuzhou
country: China
facility: Fujian Provincial cancer Hospital
state: Fujian
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Provincial Cancer Hospital
state: Henan
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical College
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
state: Jiangxi
city: Linyi
country: China
facility: Linyi Cancer Hospital
state: Shandong
city: Shanghai
country: China
facility: Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Xin Hua Hospital affiliated to Shanghai Jiao Tong University School of Medicine Chongming Branch
state: Shanghai
city: Xian
country: China
facility: Tangdu Hospital
state: Shanxi
city: Kunming
country: China
facility: Tumor Hospital of Yunnan Province The Third Affiliated Hospital of Kunming Medical University
state: Yunnan
Study officials:
affiliation: Tongji Hospital in Wuhan
name: Shiying Yu, Professor
role: PRINCIPAL_INVESTIGATOR
References: