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Study of Methylnaltrexone in Opioid-Induced Constipation Patients

Primary Purpose

Opioid-induced Constipation

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Methylnaltrexone (MNTX)
Placebo
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-induced Constipation focused on measuring opioid-induced constipation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Second Hospital of Anhui Medical UniversityRecruiting
  • Fujian Provincial cancer HospitalRecruiting
  • Zhongnan Hospital of Wuhan UniversityRecruiting
  • Harbin Medical University Cancer HospitalRecruiting
  • Henan Provincial Cancer HospitalRecruiting
  • The Affiliated Hospital of Xuzhou Medical CollegeRecruiting
  • Jiangxi Cancer HospitalRecruiting
  • Linyi Cancer HospitalRecruiting
  • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineRecruiting
  • Xin Hua Hospital affiliated to Shanghai Jiao Tong University School of Medicine Chongming BranchRecruiting
  • Tangdu HospitalRecruiting
  • Tumor Hospital of Yunnan Province The Third Affiliated Hospital of Kunming Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Drug

Placebo

Arm Description

Methylnaltrexone (MNTX) nearly 0.15mg/kg administered every other day for 2 weeks.

Placebo administered every other day for 2 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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 hours after each doses from the second dose to the last dose
The proportion of subjects who had Rescue-free laxation response within 4-24h after each dose
The proportion of subjects who had ≥3 laxation responses per week

Full Information

First Posted
October 8, 2015
Last Updated
October 10, 2015
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02574819
Brief Title
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

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-induced Constipation
Keywords
opioid-induced constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
198 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Drug
Arm Type
Experimental
Arm Description
Methylnaltrexone (MNTX) nearly 0.15mg/kg administered every other day for 2 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered every other day for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Methylnaltrexone (MNTX)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
The proportion of subjects who had the Rescue-free laxation response within 4 hours of the initial dose
Description
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.
Time Frame
up to 4 hours
Secondary Outcome Measure Information:
Title
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
Description
Record the frequency of laxation. After 1-4 dose, within 4 hours of every dose, record the dose number when bowel movement happened
Time Frame
up to 8 days
Title
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
Title
The proportion of subjects who had Rescue-free laxation response within 4-24h after each dose
Time Frame
up to 14 days
Title
The proportion of subjects who had ≥3 laxation responses per week
Time Frame
up to 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shiying Yu, Professor
Email
syyu@tjh.tjmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan Chen, Professor
Email
ychen@tjh.tjmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiying Yu, Professor
Organizational Affiliation
Tongji Hospital in Wuhan
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhendong Chen, Professor
Facility Name
Fujian Provincial cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheng Huang, Professor
Email
cheng671@sina.com
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hebei
ZIP/Postal Code
430071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Di Deng, Professor
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingyuan Zhang, Professor
Facility Name
Henan Provincial Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
451100
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenying Deng, Professor
Email
psc1969@sohu.com
Facility Name
The Affiliated Hospital of Xuzhou Medical College
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhengqiu Zhu, Professor
Facility Name
Jiangxi Cancer Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meijian Wang, Professor
Email
wangmj8@sina.com
Facility Name
Linyi Cancer Hospital
City
Linyi
State/Province
Shandong
ZIP/Postal Code
276000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhua Shi, Professor
Email
shijianhualy@126.com
Facility Name
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leizhen Zheng, Professor
Email
zhengleizhen2006@126.com
Facility Name
Xin Hua Hospital affiliated to Shanghai Jiao Tong University School of Medicine Chongming Branch
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
202150
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gang Ding, Professor
Facility Name
Tangdu Hospital
City
Xian
State/Province
Shanxi
ZIP/Postal Code
710038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helong Zhang, Professor
Email
cutdccc@126.com
Facility Name
Tumor Hospital of Yunnan Province The Third Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650118
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Runxiang Yang, Professor
Email
13888876721@163.com

12. IPD Sharing Statement

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Study of Methylnaltrexone in Opioid-Induced Constipation Patients

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