Phase 4
Completed N=190
An Efficacy and Safety Study of Hydromorphone Oral Osmotic System (OROS) in Korean Participants With Cancer Pain
Source: ClinicalTrials.gov NCT00766831 ↗Enrolled (actual)
190
Serious AEs
18.3%
Results posted
Aug 2013
Primary outcomePrimary: Percentage of Treatment Response in Sleep Disturbance Caused by Cancer Pain — 34.9 Percentage of treatment response
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Treatment Response in Sleep Disturbance Caused by Cancer Pain |
34.9 | — |
| SECONDARY Sleep Disturbance Questionnaire: Analgesic Administration |
37; 45; 25; 57 | — |
| SECONDARY Sleep Disturbance Questionnaire: Frequency of Waking Up |
8; 29; 21; 6; 13; 23 | — |
| SECONDARY Sleep Disturbance Questionnaire: Wake up Due to Unbearable Pain |
32; 50; 15; 67 | — |
| SECONDARY Korean Brief Pain Inventory (K-BPI) Questionnaire Score |
6.7; 3.6; 5.2; 4.4; 0.4; 5.0 | — |
| SECONDARY Participant's Pain Intensity |
5.3; 4.1 | — |
| SECONDARY Number of Times the Short-Acting Opioid Analgesic Administered for Breakthrough Pain |
0.92; 0.36 | — |
| SECONDARY Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score |
1; 53; 23; 4; 1; 52 | — |
| SECONDARY Number of Participants With Clinical Global Impression-Improvement (CGI-Improvement) Score |
1; 21; 37; 20; 2; 1 | — |
| SECONDARY Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Participants |
7; 29; 38; 8 | — |
| SECONDARY Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Investigators |
7; 32; 32; 10; 1 | — |
| SECONDARY Percentage of Participants Who Preferred the Oral Long-Action Opioids Analgesic or Study Drug |
80.5; 19.5 | — |
| SECONDARY Percentage of Participants With Different Reasons for Their Preference for Oral Long-Action Opioids Analgesic or Study Drug |
1.5; 37.5; 31.8; 50.0; 54.6; 12.5 | — |
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)
Data sourced from ClinicalTrials.gov (NCT00766831). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.