MedTrace Logo

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

NCT00766831 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2013-10-23

Study results available
· View outcomes & findings →

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.

Conditions

  • Cancer Pain

Interventions

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.

Sponsors & Collaborators

  • Janssen Korea, Ltd., Korea

    lead INDUSTRY

Principal Investigators

  • Janssen Korea, Ltd. Clinical Trial · Janssen Korea, Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-06-30
Completion
2010-06-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00766831 on ClinicalTrials.gov