Study of Methylnaltrexone in Opioid-Induced Constipation Patients
NCT ID: NCT02574819
Last Updated: 2015-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2/PHASE3
198 participants
INTERVENTIONAL
2015-04-30
2017-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Oral Methylnaltrexone (MNTX) for the Treatment of Opioid-Induced Constipation (OIC) in Participants With Chronic, Non-Malignant Pain
NCT01186770
Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness
NCT00672477
Compassionate Use Study of Methylnaltrexone
NCT01368562
Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness
NCT00672139
Methylnaltrexone for Opioid-induced Constipation in Cancer Patients
NCT01004393
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Drug
Methylnaltrexone (MNTX) nearly 0.15mg/kg administered every other day for 2 weeks.
Methylnaltrexone (MNTX)
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
Placebo administered every other day for 2 weeks.
Placebo
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Methylnaltrexone (MNTX)
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
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Shiying Yu, Professor
Role: PRINCIPAL_INVESTIGATOR
Tongji Hospital in Wuhan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Fujian Provincial cancer Hospital
Fuzhou, Fujian, China
Zhongnan Hospital of Wuhan University
Wuhan, Hebei, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Provincial Cancer Hospital
Zhengzhou, Henan, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Linyi Cancer Hospital
Linyi, Shandong, China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Xin Hua Hospital affiliated to Shanghai Jiao Tong University School of Medicine Chongming Branch
Shanghai, Shanghai Municipality, China
Tangdu Hospital
Xian, Shanxi, China
Tumor Hospital of Yunnan Province The Third Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Zhendong Chen, Professor
Role: primary
Di Deng, Professor
Role: primary
Qingyuan Zhang, Professor
Role: primary
Zhengqiu Zhu, Professor
Role: primary
Gang Ding, Professor
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CTTQ-MNTX
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.