Study of Methylnaltrexone in Opioid-Induced Constipation Patients
Methylnaltrexone (MNTX) for Treatment of Opioid-induced Constipation in Advanced Illness Patients : a Multicenter, Randomized, Double-blind , Placebo-controlled Trail
1 other identifier
interventional
198
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2015
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 8, 2015
CompletedFirst Posted
Study publicly available on registry
October 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedOctober 14, 2015
October 1, 2015
1.7 years
October 8, 2015
October 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
up to 4 hours
Secondary Outcomes (4)
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
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 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
Study Arms (2)
Drug
EXPERIMENTALMethylnaltrexone (MNTX) nearly 0.15mg/kg administered every other day for 2 weeks.
Placebo
PLACEBO COMPARATORPlacebo administered every other day for 2 weeks.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230032, China
Fujian Provincial cancer Hospital
Fuzhou, Fujian, 350009, China
Zhongnan Hospital of Wuhan University
Wuhan, Hebei, 430071, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
Henan Provincial Cancer Hospital
Zhengzhou, Henan, 451100, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, 221000, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029, China
Linyi Cancer Hospital
Linyi, Shandong, 276000, China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092, China
Xin Hua Hospital affiliated to Shanghai Jiao Tong University School of Medicine Chongming Branch
Shanghai, Shanghai Municipality, 202150, China
Tangdu Hospital
Xian, Shanxi, 710038, China
Tumor Hospital of Yunnan Province The Third Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650118, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shiying Yu, Professor
Tongji Hospital in Wuhan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2015
First Posted
October 14, 2015
Study Start
April 1, 2015
Primary Completion
December 1, 2016
Study Completion
April 1, 2017
Last Updated
October 14, 2015
Record last verified: 2015-10