Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness

Opioid-Induced Constipation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00672477
• Other study ID #: 3200K1-4000
• Secondary ID: B2541005
• Status: Completed
• Phase: Phase 4
• First received: May 2, 2008
• Last updated: February 7, 2018
• Start date: June 2008
• Est. completion date: February 2013

Study information

• Verified date: February 2018
• Source: Valeant Pharmaceuticals International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constipation
• Opioid-Induced Constipation

Intervention

Drug:
• Methylnaltrexone

• Placebo

Locations

Country	Name	City	State
Australia	Salix Investigational Site	Coburg	Victoria
Australia	Salix Investigational Site	Darlinghurst	New South Wales
Australia	Salix Investigational Site	East Melbourne	Victoria
Belgium	Salix Investigational Site	Leuven
Brazil	Salix Investigational Site	Liberdade	Sao Paulo
Brazil	Salix Investigational Site	Sao Paulo	SP
Canada	Salix Investigational Site	Edmonton	Alberta
Canada	Salix Investigational Site	Hamilton	Ontario
Canada	Salix Investigational Site	Montreal	Quebec
Canada	Salix Investigational Site	Montreal	Quebec
Canada	Salix Investigational Site	Quebec
Canada	Salix Investigational Site	Winnipeg	Manitoba
France	Salix Investigational Site	Besancon
France	Salix Investigational Site	Bordeaux
France	Salix Investigational Site	Bordeaux
France	Salix Investigational Site	Grenoble
France	Salix Investigational Site	Montpellier
France	Salix Investigational Site	Villejuif
Germany	Salix Investigational Site	Aachen
Germany	Salix Investigational Site	Berlin
Germany	Salix Investigational Site	Muenchen
Italy	Salix Investigational Site	L'Aquila
Italy	Salix Investigational Site	Milan
Italy	Salix Investigational Site	Milano
Mexico	Pfizer Investigational Site	Mexico City DF
Spain	Salix Investigational Site	Barcelona
Spain	Salix Investigational Site	L'Hospitalet De Llobregat
Spain	Salix Investigational Site	Sevilla
Sweden	Salix Investigational Site	Kungsbacka
Sweden	Salix Investigational Site	Norrköping
United Kingdom	Salix Investigational Site	Cheltenham	Gloucestershire
United States	Salix Investigational Site	Albuquerque	New Mexico
United States	Salix Investigational Site	American Fork	Utah
United States	Salix Investigational Site	Auburndale	Florida
United States	Salix Investigational Site	Aurora	Colorado
United States	Salix Investigational Site	Austin	Texas
United States	Salix Investigational Site	Cleveland	Ohio
United States	Salix Investigational Site	Flat Rock	North Carolina
United States	Salix Investigational Site	Houston	Texas
United States	Salix Investigational Site	Hudson	Florida
United States	Salix Investigational Site	Laguna Hills	California
United States	Salix Investigational Site	Lakeland	Florida
United States	Salix Investigational Site	Lakeland	Florida
United States	Salix Investigational Site	Lancaster	California
United States	Salix Investigational Site	Madison	Wisconsin
United States	Salix Investigational Site	Miami Springs	Florida
United States	Salix Investigational Site	Mobile	Alabama
United States	Salix Investigational Site	Orange	New Jersey
United States	Salix Investigational Site	Orem	Utah
United States	Salix Investigational Site	Philadelphia	Pennsylvania
United States	Salix Investigational Site	Provo	Utah
United States	Salix Investigational Site	Ruskin	Florida
United States	Salix Investigational Site	Salt Lake City	Utah
United States	Salix Investigational Site	Sebring	Florida
United States	Salix Investigational Site	Tampa	Florida
United States	Salix Investigational Site	Tampa	Florida
United States	Salix Investigational Site	Tampa	Florida
United States	Salix Investigational Site	Temple Terrace	Florida
United States	Salix Investigational Site	West Palm Beach	Florida
United States	Salix Investigational Site	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Valeant Pharmaceuticals International, Inc.	Progenics Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  France,  Germany,  Italy,  Mexico,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Proportion of Subjects Who Have a Rescue-free Laxation Response Within 4 Hours After at Least 2 of the First 4 Doses	This outcome measures the proportion of subjects who had a rescue-free laxation (ie, bowel movement) within 4 hours after at least 2 of the first 4 doses of study drug. A "rescue free" laxation was defined as a laxation without use of any rescue medication or rescue procedures within 4 hours prior to the laxation.	7 days
Secondary	Time to First Rescue-free Laxation (Following the First Dose of Study Drug).	This outcome measures the time from first dose of study drug to the first rescue-free laxation (ie, bowel movement). A "rescue free" laxation was defined as a laxation without use of any rescue medication or rescue procedures within 4 hours prior to the laxation.	14 days