Clinical trial NCT00672139: Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness
Official title: Open-Label Extension Study To Assess The Safety Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Subjects With Advanced Illness And Opioid-Induced Constipation
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: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will be tested in late stage, advanced illness patients who have constipation caused by opioid pain relievers. This study will last 3 months.


Eligibility criteria: Inclusion Criteria:

* Has completed study 3200K1-4000-WW, including 2 weeks of therapy and completion of all post baseline efficacy, safety, and health outcomes assessments.
* Is receiving opioids on a regular schedule, not just as needed to control pain.
* Likely to continue to need treatment of OIC for the duration of participation in the study.

Exclusion Criteria:

* Has a suspected mechanical gastrointestinal obstruction, fecal impaction, or clinically important active diverticular disease as determined by the investigator.
* Currently using an opioid antagonist or partial antagonist.
* Has any other clinically important abnormalities such that risk to patient of participation outweighs the potential benefit of therapy as determined by the investigator

Primary outcomes:
measure: Number of Laxations Per Subject Within 24 Hours of Dosing Per Week.
timeFrame: 10 weeks
Secondary outcomes:
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: Orange
country: United States
facility: Salix Investigational Site
state: New Jersey
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: Madison
country: United States
facility: Salix Investigational Site
state: Wisconsin
city: Coburg
country: Australia
facility: Salix Investigational Site
state: Victoria
city: East Melbourne
country: Australia
facility: Salix Investigational Site
state: Victoria
city: Adelaide
country: Australia
facility: Salix Investigational Site
city: Leuven
country: Belgium
facility: Salix Investigational Site
city: Edmonton
country: Canada
facility: Salix Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: Salix Investigational Site
state: Alberta
city: Hamilton
country: Canada
facility: Salix Investigational Site
state: Ontario
city: London
country: Canada
facility: Salix Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Salix Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: Salix Investigational Site
city: Montpellier
country: France
facility: Salix Investigational Site
city: Berlin
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: Roma
country: Italy
facility: Salix Investigational Site
city: Mexico City DF
country: Mexico
facility: Pfizer Investigational Site
city: Almada
country: Portugal
facility: Salix Investigational Site
city: Porto
country: Portugal
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: