View Clinical Trial (Medical Research Study)
Open-Label Extension Study To Assess The Safety Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Subjects With Advanced Illness And Opioid-Induced Constipation
| City: |
|
Cleveland |
| State: |
|
Ohio |
| Zip Code: |
|
44119 |
| Conditions: |
|
Opioid-Induced Constipation |
| Purpose: |
|
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.
|
| Study Summary: |
|
|
| 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
|
| NCT ID: |
|
NCT00672139 |
| Primary Contact: |
|
Study Director
Bob Rolleri
Salix Pharmaceuticals
Dave Mathews
Phone: 919-862-1000
Email: dave.mathews@salix.com
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Cleveland, Ohio 44119
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 21, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|