Compassionate Use Study of Methylnaltrexone
This is an open label compassionate use study of subcutaneously administered MNTX in subjects with advance medical illness and opioid-induced constipation. Eligible subjects were to initially receive a single dose of MNTX delivered SC. Subsequent dosing could have been adjusted upward to achieve a desired clinical response or lowered to alleviate drug related adverse events (AEs).
Salix Pharmaceuticals has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Compassionate Use Study of Methylnaltrexone in Patients With Opioid-Induced Side Effects|
- Number of patients with side effects of opioid-induced constipation. [ Time Frame: 6 months ] [ Designated as safety issue: No ]To provide subcutaneously administered MNTX to advanced medical illness patients on a compassionate basis in order to alleviate the side effects of opioid-induced constipation.
|Study Start Date:||January 2003|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368562
|United States, New York|
|Progenics Pharmaceuticals, Inc.|
|Tarrytown, New York, United States, 10591|
|Study Director:||Tage Ramakrishna, MD||Progenics Pharmaceuticals, Inc.|