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
| City: |
|
Lakeland |
| State: |
|
Florida |
| Zip Code: |
|
33805 |
| Conditions: |
|
Opioid-Induced Constipation |
| Purpose: |
|
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.
|
| Study Summary: |
|
|
| Criteria: |
|
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.
|
| NCT ID: |
|
NCT00672477 |
| 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: |
|
Lakeland, Florida 33805
United States
There is no listed contact information for this specific location.
Site Status: Completed |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 18, 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
|