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Study of Methylnaltrexone in Opioid-Induced Constipation Patients

NCT02574819 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2015-10-14

No results posted yet for this study

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.

Conditions

  • Opioid-induced Constipation

Interventions

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.

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.

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Shiying Yu, Professor · Tongji Hospital in Wuhan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-12-31
Completion
2017-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02574819 on ClinicalTrials.gov