NCT00766831

An Efficacy and Safety Study of Hydromorphone Oral Osmotic System (OROS) in Korean Participants With Cancer Pain

Hydromorphone OROS in Korean Cancer Patients: Evaluation of Its Clinical Usefulness in Improvement of Sleep Disturbance

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: Janssen Korea, Ltd., Korea · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this is study to evaluate improvement of sleep disorder caused by cancer pain after the administration of Hydromorphone Oral Osmotic System (OROS) in Korean participants with cancer.

Detailed description

This is an open-label (all people know the identity of the intervention), multi-center (conducted in more than 1 center), prospective (study following participants forward in time) dose-ascending study to evaluate the clinical usefulness of hydromorphone OROS in improvement of sleep disturbance caused by cancer pain.Total duration of study will be 3 weeks. The study consists of 3 phases: Screening phase (up to 1 week), Treatment phase (2 weeks), and Extension phase (12 weeks). The study will include 6 visits: Day -7, Day 1, Day 15, Day 43, Day 71, and Day 99. During screening phase, potential participants will receive strong oral (long acting) opioid analgesic (for 7 days) until Day 1 and the participants will be evaluated for participation in clinical study on Day 1. During treatment phase, participants will receive hydromorphone OROS (8 milligram \[mg\] to greater than or equal to 32 mg), once daily for 2 weeks, and the dose will be adjusted every 2 days from Day 3 at the Investigator's discretion and according to the strong oral (long acting) opioid analgesic administered from screening phase to Day 1 (the initial dose of the study drug will be determined by converting the dose of the previously administered analgesic to that of the daily dose of oral morphine with the equivalent analgesic effect to the study drug \[dose with equivalent analgesic effect; Hydromorphone OROS dose: oral morphine dose =1:5\]). Participants who completed treatment phase and suffer from continuing cancer pain will be enrolled to extension phase and study drug will be administered as per Investigator discretion for 99 days. Participants primarily will be evaluated for improvement in sleep disturbance measured by Korean Brief Pain Inventory (KBPI). Participants' safety will be monitored throughout the study.

Conditions

• Cancer Pain

Interventions

Type	Name	Description
DRUG	Hydromorphone	Participants will receive hydromorphone OROS (8 milligram \[mg\] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS will be continued as per Investigator's discretion for additional 84 days of extension phase.

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2008-10-06
• Last updated: 2013-10-23
• Results posted: 2013-08-26