Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness

Opioid-Induced Constipation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00672139
• Other study ID #: 3200K1-4001
• Secondary ID: B2541006
• Status: Completed
• Phase: Phase 4
• First received: May 2, 2008
• Last updated: February 7, 2018
• Start date: July 2008
• Est. completion date: May 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: May 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Opioid-Induced Constipation

Intervention

Drug:
• Methylnaltrexone bromide

Locations

Country	Name	City	State
Australia	Salix Investigational Site	Adelaide
Australia	Salix Investigational Site	Coburg	Victoria
Australia	Salix Investigational Site	East Melbourne	Victoria
Belgium	Salix Investigational Site	Leuven
Canada	Salix Investigational Site	Edmonton	Alberta
Canada	Salix Investigational Site	Edmonton	Alberta
Canada	Salix Investigational Site	Hamilton	Ontario
Canada	Salix Investigational Site	London	Ontario
Canada	Salix Investigational Site	Montreal	Quebec
Canada	Salix Investigational Site	Quebec
France	Salix Investigational Site	Montpellier
Germany	Salix Investigational Site	Berlin
Italy	Salix Investigational Site	L'Aquila
Italy	Salix Investigational Site	Milan
Italy	Salix Investigational Site	Milano
Italy	Salix Investigational Site	Roma
Mexico	Pfizer Investigational Site	Mexico City DF
Portugal	Salix Investigational Site	Almada
Portugal	Salix Investigational Site	Porto
United Kingdom	Salix Investigational Site	Cheltenham	Gloucestershire
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	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	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,  Canada,  France,  Germany,  Italy,  Mexico,  Portugal,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Laxations Per Subject Within 24 Hours of Dosing Per Week.	This was defined as the total number of days with a laxation (ie, a bowel movement) within 24 hours after dosing in each 7-day interval after the start of dosing. Results shown are the ranges (lowest and highest weekly values) of mean (± standard deviation) numbers of laxations within 24 hours of dosing per week during the 10-week treatment period for each group.	10 weeks