NCT01532895

Clinical Usefulness and Quality of Life of OROS Hydromorphone in Patients Who Have Not Been Treated With a Strong Opioid

Clinical Usefulness and Quality of Life of OROS Hydromorphone in Strong Opioid-Naïve Cancer Pain Patients; Multicenter, Prospective, Open-Label and Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 400 (actual)
• Sponsor: Janssen Korea, Ltd., Korea · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to evaluate the usefulness of hydromorphone to treat cancer pain in patients who have not been treated with a strong opioid.

Detailed description

This is a multicenter, prospective, open-label (all people know the identity of the intervention) and observational study. Patients selected for the proposed study are patients complaining of cancer pain who visit or are hospitalized at the research centers during the study, who are not being treated with strong continuous opioid (narcotic medication used against the pain), and who require cancer pain control with hydromorphone, at the investigator's discretion. The study will evaluate the changes in pain relief, level of sleep deprivation, and the patients' quality of life before and after administration of hydromorphone.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Hydromorphone HCI OROS	type= exact number, unit= mg, number=4, form= tablet, route= oral use. One tablet administered once a day. The dose may be increased if the level of pain increases or if the pain-killing effect is insufficient.

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-09-01
• Completion: 2012-10-01
• First posted: 2012-02-15
• Last updated: 2014-03-18

Locations

11 sites across 1 country: South Korea