106
Participants
Start Date
December 31, 2011
Primary Completion Date
September 30, 2012
Study Completion Date
September 30, 2012
OROS hydromorphone
Type= exact number, unit= mg, number= 4, form= tablet, route= oral, administered from 1st evaluation day (Day 1) to 2nd evaluation day (Day 15±2). Dosage adjustment: If NRS (Numeric Rating Scale) =4 or more then dose can be increased by 4mg until the average pain intensity for the past 24 hours is adjusted to lower than NRS 3. For the treatment of breakthrough pain, if necessary the one-time administration dose of quick-effect OROS Hydromorphone shall be 2mg up to the daily dosage of the study medicine, 12mg.
Cheonan
Cheongju-si
Daejeon
Hwasun Gun
Jeonju
Jinju
Janssen Korea, Ltd., Korea
INDUSTRY