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

Completed · Phase 4

Conditions studied: Opioid-Induced Constipation

In brief

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.

Key facts

Study ID

NCT00672139

Run by

Bausch Health Americas, Inc.

People needed

156

Starts

2008-07-01

Expected to finish

2013-05-01

Last updated by the study team

2018-03-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Salix Investigational Site — Mobile, Alabama, United States
• Salix Investigational Site — Laguna Hills, California, United States
• Salix Investigational Site — Lancaster, California, United States
• Salix Investigational Site — Aurora, Colorado, United States
• Salix Investigational Site — Auburndale, Florida, United States
• Salix Investigational Site — Hudson, Florida, United States
• Salix Investigational Site — Lakeland, Florida, United States
• Salix Investigational Site — Lakeland, Florida, United States
• Salix Investigational Site — Miami Springs, Florida, 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 — Orange, New Jersey, United States
• Salix Investigational Site — Flat Rock, North Carolina, United States
• Salix Investigational Site — Winston-Salem, North Carolina, United States
• Salix Investigational Site — Cleveland, Ohio, United States
• Salix Investigational Site — Philadelphia, Pennsylvania, United States
• Salix Investigational Site — Austin, Texas, United States
• Salix Investigational Site — Houston, Texas, United States
• Salix Investigational Site — American Fork, Utah, United States
• Salix Investigational Site — Orem, Utah, United States
• Salix Investigational Site — Provo, Utah, United States

Full record on ClinicalTrials.gov

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