17
Participants
Start Date
July 31, 2007
Primary Completion Date
July 31, 2013
Study Completion Date
July 31, 2013
Modified-release morphine
During the first three weeks of each treatment (drug or placebo), the dose will be escalated toward a maximally tolerated dose or a dose sufficient to eliminate pain (up to a ceiling dose of 120 mg), whichever is reached first. During the entire fourth and fifth week of each period, subjects will receive their maximally tolerated dose of study medication. During the sixth and seventh weeks, they will undergo a seven-day dose tapering and a seven-day complete washout of the study drug.
Placebo
Mount Sinai School of Medicine, New York
U.S. Department of Education
FED
Icahn School of Medicine at Mount Sinai
OTHER