Study to Evaluate Effectiveness and Tolerability of OROS Hydromorphone for Cancer Pain Treatment in Korean Patients

PHASE4CompletedINTERVENTIONAL
Enrollment

106

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

September 30, 2012

Study Completion Date

September 30, 2012

Conditions
Cancer Pain
Interventions
DRUG

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.

Trial Locations (6)

Unknown

Cheonan

Cheongju-si

Daejeon

Hwasun Gun

Jeonju

Jinju

All Listed Sponsors
lead

Janssen Korea, Ltd., Korea

INDUSTRY

NCT01621100 - Study to Evaluate Effectiveness and Tolerability of OROS Hydromorphone for Cancer Pain Treatment in Korean Patients | Biotech Hunter | Biotech Hunter