Study of Methylnaltrexone in Opioid-Induced Constipation Patients

Opioid-induced Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02574819
• Other study ID #: CTTQ-MNTX
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: October 8, 2015
• Last updated: October 10, 2015
• Start date: April 2015
• Est. completion date: April 2017

Study information

• Verified date: October 2015
• Source: Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
• Contact: Shiying Yu, Professor
• Email: syyu[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 198
• Est. completion date: April 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Opioid-induced Constipation

Intervention

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
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.

Locations

Country	Name	City	State
China	Fujian Provincial cancer Hospital	Fuzhou	Fujian
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	The Second Hospital of Anhui Medical University	Hefei	Anhui
China	Tumor Hospital of Yunnan Province The Third Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Linyi Cancer Hospital	Linyi	Shandong
China	Jiangxi Cancer Hospital	Nanchang	Jiangxi
China	Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Xin Hua Hospital affiliated to Shanghai Jiao Tong University School of Medicine Chongming Branch	Shanghai	Shanghai
China	Zhongnan Hospital of Wuhan University	Wuhan	Hebei
China	Tangdu Hospital	Xian	Shanxi
China	The Affiliated Hospital of Xuzhou Medical College	Xuzhou	Jiangsu
China	Henan Provincial Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	up to 8 days	No
Secondary	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	No
Secondary	The proportion of subjects who had Rescue-free laxation response within 4-24h after each dose		up to 14 days	No
Secondary	The proportion of subjects who had =3 laxation responses per week		up to 2 weeks	No