Study of Methylnaltrexone in Opioid-Induced Constipation Patients

October 10, 2015 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Methylnaltrexone (MNTX) for Treatment of Opioid-induced Constipation in Advanced Illness Patients : a Multicenter, Randomized, Double-blind , Placebo-controlled Trail

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

198

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230032
        • Recruiting
        • The Second Hospital of Anhui Medical University
        • Contact:
          • Zhendong Chen, Professor
    • Fujian
      • Fuzhou, Fujian, China, 350009
        • Recruiting
        • Fujian Provincial Cancer Hospital
        • Contact:
    • Hebei
      • Wuhan, Hebei, China, 430071
        • Recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:
          • Di Deng, Professor
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
          • Qingyuan Zhang, Professor
    • Henan
      • Zhengzhou, Henan, China, 451100
        • Recruiting
        • Henan Provincial Cancer Hospital
        • Contact:
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221000
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical College
        • Contact:
          • Zhengqiu Zhu, Professor
    • Jiangxi
      • Nanchang, Jiangxi, China, 330029
        • Recruiting
        • Jiangxi Cancer Hospital
        • Contact:
    • Shandong
      • Linyi, Shandong, China, 276000
    • Shanghai
      • Shanghai, Shanghai, China, 200092
        • Recruiting
        • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Contact:
      • Shanghai, Shanghai, China, 202150
        • Recruiting
        • Xin Hua Hospital affiliated to Shanghai Jiao Tong University School of Medicine Chongming Branch
        • Contact:
          • Gang Ding, Professor
    • Shanxi
      • Xian, Shanxi, China, 710038
        • Recruiting
        • Tangdu Hospital
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650118
        • Recruiting
        • Tumor Hospital of Yunnan Province The Third Affiliated Hospital of Kunming Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drug
Methylnaltrexone (MNTX) nearly 0.15mg/kg administered every other day for 2 weeks.
Drug: 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 Comparator: Placebo
Placebo administered every other day for 2 weeks.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of subjects who had the Rescue-free laxation response within 4 hours of the initial dose
Time Frame: 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.
up to 4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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
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
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
up to 14 days
The proportion of subjects who had ≥3 laxation responses per week
Time Frame: up to 2 weeks
up to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Investigators

  • Principal Investigator: Shiying Yu, Professor, Tongji Hospital in Wuhan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

October 8, 2015

First Submitted That Met QC Criteria

October 10, 2015

First Posted (Estimate)

October 14, 2015

Study Record Updates

Last Update Posted (Estimate)

October 14, 2015

Last Update Submitted That Met QC Criteria

October 10, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTTQ-MNTX

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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