Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness
Status: | Completed |
---|---|
Conditions: | Constipation |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/17/2018 |
Start Date: | July 2008 |
End Date: | May 2013 |
Open-Label Extension Study To Assess The Safety Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Subjects With Advanced Illness And Opioid-Induced Constipation
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.
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.
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
We found this trial at
27
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials