Clinical trial NCT00766831: An Efficacy and Safety Study of Hydromorphone Oral Osmotic System (OROS) in Korean Participants With Cancer Pain
Official title: Hydromorphone OROS in Korean Cancer Patients: Evaluation of Its Clinical Usefulness in Improvement of Sleep Disturbance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cancer Pain
Keywords: Cancer pain
Hydromorphone OROS
Jurnista
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2008-10-06
Enrollment: 190
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility 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)

Primary outcomes:
measure: Percentage of Treatment Response in Sleep Disturbance Caused by Cancer Pain
timeFrame: Day 15 or Early withdrawal
Secondary outcomes:
measure: Sleep Disturbance Questionnaire: Analgesic Administration
timeFrame: Baseline and Day 15
measure: Sleep Disturbance Questionnaire: Frequency of Waking Up
timeFrame: Baseline and Day 15
measure: Sleep Disturbance Questionnaire: Wake up Due to Unbearable Pain
timeFrame: Baseline and Day 15
measure: Korean Brief Pain Inventory (K-BPI) Questionnaire Score
timeFrame: Baseline and Day 15
measure: Participant's Pain Intensity
timeFrame: Baseline and Day 15
measure: Number of Times the Short-Acting Opioid Analgesic Administered for Breakthrough Pain
timeFrame: Baseline and Day 15
measure: Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score
timeFrame: Baseline and Day 15
measure: Number of Participants With Clinical Global Impression-Improvement (CGI-Improvement) Score
timeFrame: Day 15
measure: Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Participants
timeFrame: Day 15
measure: Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Investigators
timeFrame: Day 15
measure: Percentage of Participants Who Preferred the Oral Long-Action Opioids Analgesic or Study Drug
timeFrame: Day 15
measure: Percentage of Participants With Different Reasons for Their Preference for Oral Long-Action Opioids Analgesic or Study Drug
timeFrame: Day 15
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Korea, Ltd.
name: Janssen Korea, Ltd. Clinical Trial
role: STUDY_DIRECTOR
References: