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