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

Information source: Janssen Korea, Ltd., Korea
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cancer Pain

Intervention: Hydromorphone (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Janssen Korea, Ltd., Korea

Official(s) and/or principal investigator(s):
Janssen Korea, Ltd. Clinical Trial, Study Director, Affiliation: Janssen Korea, Ltd.


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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of Treatment Response in Sleep Disturbance Caused by Cancer Pain

Secondary outcome:

Sleep Disturbance Questionnaire: Analgesic Administration

Sleep Disturbance Questionnaire: Frequency of Waking Up

Sleep Disturbance Questionnaire: Wake up Due to Unbearable Pain

Korean Brief Pain Inventory (K-BPI) Questionnaire Score

Participant's Pain Intensity

Number of Times the Short-Acting Opioid Analgesic Administered for Breakthrough Pain

Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score

Number of Participants With Clinical Global Impression-Improvement (CGI-Improvement) Score

Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Participants

Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Investigators

Percentage of Participants Who Preferred the Oral Long-Action Opioids Analgesic or Study Drug

Percentage of Participants With Different Reasons for Their Preference for Oral Long-Action Opioids Analgesic or Study Drug

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.


Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Participants who are currently receiving strong opioid analgesic (drug used to

control pain) for their cancer pain management

- Participants whose arithmetical mean of sleep disturbance caused by pain measured

with Numeric Rating Scale for 3 days before Visit 2 (Day 1) is equal to or greater than 4 points

- Participants who are able, in the opinion of Investigator, to comply fully with the

trial requirements including completion of the Korean-Brief Pain Inventory

- Participants who have signed an informed consent form

Exclusion Criteria:

- Participants with pain who are not likely to response to opioid analgesics

- Participants who are intolerant or hypersensitive to hydromorphone

- Participants with the following digestive tract diseases which is serious enough to

interfere action of an oral analgesic; diseases which can affect absorption and transit of oral drugs such as dysphagia (trouble swallowing), vomiting, no bowel movement, intestinal obstruction, serious intestinal stenosis (narrowing of a duct, tube, or 1 of the valves in the heart), etc

- Female participants of childbearing potential who are pregnant or lactating, seeking

pregnancy, or failing to take adequate contraceptive precautions

- Participants in whom the risks of treatment with morphine/hydromorphone outweigh the

potential benefits, including such risk categories as raised intracranial pressure, hypotension, hypothyroidism, asthma, compromised respiratory function compromised liver function, convulsive (an involuntary contraction or series of contractions of the voluntary muscles) disorder and Addison disease (disorder that occurs when the adrenal glands do not produce enough of their hormones)

Locations and Contacts

Additional Information

Starting date: October 2008
Last updated: September 13, 2013

Page last updated: August 23, 2015

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