Clinical trial NCT00672477: Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness
Official title: A Randomized, Double-Blind, Placebo-Controlled Study Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Adults With Advanced Illness And Opioid-Induced Constipation: Efficacy, Safety, And Additional Health Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Opioid-Induced Constipation
Keywords: opioid-induced constipation
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Progenics Pharmaceuticals, Inc.
First posted: 2008-05-06
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of methylnaltrexone administered as subcutaneous injections in subjects who have opioid-induced constipation and an advanced illness. The hypothesis is that methylnaltrexone will be safe and effective in relieving opioid-induced constipation in these subjects.


Eligibility criteria: Inclusion Criteria:

* Is an adult 18 years of age or older
* Has a diagnosis of advanced illness (ie, a terminal illness such as incurable cancer or other end-stage disease)
* Has a life expectancy of at least 1 month.
* Is receiving opioids on a regular schedule (not just as-needed or rescue doses) for the control of pain or discomfort for at least 2 weeks before the first dose of study drug.
* Has constipation that is caused by opioid medications.

Exclusion Criteria:

* Has a known or suspected allergy to methylnaltrexone or other similar compounds (e.g. naltrexone or naloxone).
* Has a known or suspected mechanical gastrointestinal obstruction.
* Has any potential nonopioid cause of bowel dysfunction that might be a major contributor to the constipation.
* Has any other clinically important abnormalities as determined by the investigator that may interfere with his or her participation in or compliance with the study.
* Receiving opioid antagonist or partial antagonist products.

Primary outcomes:
measure: The Proportion of Subjects Who Have a Rescue-free Laxation Response Within 4 Hours After at Least 2 of the First 4 Doses
timeFrame: 7 days
Secondary outcomes:
measure: Time to First Rescue-free Laxation (Following the First Dose of Study Drug).
timeFrame: 14 days
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Salix Investigational Site
state: Alabama
city: Laguna Hills
country: United States
facility: Salix Investigational Site
state: California
city: Lancaster
country: United States
facility: Salix Investigational Site
state: California
city: Aurora
country: United States
facility: Salix Investigational Site
state: Colorado
city: Auburndale
country: United States
facility: Salix Investigational Site
state: Florida
city: Hudson
country: United States
facility: Salix Investigational Site
state: Florida
city: Lakeland
country: United States
facility: Salix Investigational Site
state: Florida
city: Lakeland
country: United States
facility: Salix Investigational Site
state: Florida
city: Miami Springs
country: United States
facility: Salix Investigational Site
state: Florida
city: Ruskin
country: United States
facility: Salix Investigational Site
state: Florida
city: Sebring
country: United States
facility: Salix Investigational Site
state: Florida
city: Tampa
country: United States
facility: Salix Investigational Site
state: Florida
city: Tampa
country: United States
facility: Salix Investigational Site
state: Florida
city: Tampa
country: United States
facility: Salix Investigational Site
state: Florida
city: Temple Terrace
country: United States
facility: Salix Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Salix Investigational Site
state: Florida
city: Orange
country: United States
facility: Salix Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Salix Investigational Site
state: New Mexico
city: Flat Rock
country: United States
facility: Salix Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Salix Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: Salix Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: Salix Investigational Site
state: Pennsylvania
city: Austin
country: United States
facility: Salix Investigational Site
state: Texas
city: Houston
country: United States
facility: Salix Investigational Site
state: Texas
city: American Fork
country: United States
facility: Salix Investigational Site
state: Utah
city: Orem
country: United States
facility: Salix Investigational Site
state: Utah
city: Provo
country: United States
facility: Salix Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Salix Investigational Site
state: Utah
city: Madison
country: United States
facility: Salix Investigational Site
state: Wisconsin
city: Darlinghurst
country: Australia
facility: Salix Investigational Site
state: New South Wales
city: Coburg
country: Australia
facility: Salix Investigational Site
state: Victoria
city: East Melbourne
country: Australia
facility: Salix Investigational Site
state: Victoria
city: Leuven
country: Belgium
facility: Salix Investigational Site
city: Liberdade
country: Brazil
facility: Salix Investigational Site
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Salix Investigational Site
state: SP
city: Edmonton
country: Canada
facility: Salix Investigational Site
state: Alberta
city: Winnipeg
country: Canada
facility: Salix Investigational Site
state: Manitoba
city: Hamilton
country: Canada
facility: Salix Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Salix Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Salix Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: Salix Investigational Site
city: Besancon
country: France
facility: Salix Investigational Site
city: Bordeaux
country: France
facility: Salix Investigational Site
city: Bordeaux
country: France
facility: Salix Investigational Site
city: Grenoble
country: France
facility: Salix Investigational Site
city: Montpellier
country: France
facility: Salix Investigational Site
city: Villejuif
country: France
facility: Salix Investigational Site
city: Aachen
country: Germany
facility: Salix Investigational Site
city: Berlin
country: Germany
facility: Salix Investigational Site
city: Muenchen
country: Germany
facility: Salix Investigational Site
city: L'Aquila
country: Italy
facility: Salix Investigational Site
city: Milano
country: Italy
facility: Salix Investigational Site
city: Milan
country: Italy
facility: Salix Investigational Site
city: Mexico City DF
country: Mexico
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Salix Investigational Site
city: L'Hospitalet De Llobregat
country: Spain
facility: Salix Investigational Site
city: Sevilla
country: Spain
facility: Salix Investigational Site
city: Kungsbacka
country: Sweden
facility: Salix Investigational Site
city: Norrköping
country: Sweden
facility: Salix Investigational Site
city: Cheltenham
country: United Kingdom
facility: Salix Investigational Site
state: Gloucestershire
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Enoch Bortey
role: STUDY_DIRECTOR
References:
citation: Liao SS, Slatkin NE, Stambler N. The Influence of Age on Central Effects of Methylnaltrexone in Patients with Opioid-Induced Constipation. Drugs Aging. 2021 Jun;38(6):503-511. doi: 10.1007/s40266-021-00850-w. Epub 2021 Mar 31.
citation: Janku F, Johnson LK, Karp DD, Atkins JT, Singleton PA, Moss J. Treatment with methylnaltrexone is associated with increased survival in patients with advanced cancer. Ann Oncol. 2016 Nov;27(11):2032-2038. doi: 10.1093/annonc/mdw317. Epub 2016 Aug 29.