Clinical trial · Observational
An Observational Study to Investigate Clinical Usefulness of OROS Hydromorphone in Korean Cancer Patients
An Open-label, Multi-center, Non-interventional Study to Investigate Clinical Usefulness of Hydromorphone OROS in Korean Cancer Patients
NCT01273454CI-TRIAL-00011978completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to collect clinical information and to examine the usefulness and safety of ORal Osmotic System Hydromorphone in Korean cancer patients. The decision to treat patients with drug is as per physician discretion and that doses are determined based upon approved labeling recommendations and physician discretion.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OROS Hydromorphone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 001
- description
- OROS Hydromorphone 8 16 32 mg once a day for 4 weeks
- interventionNames
- Drug: OROS Hydromorphone
Primary outcomes (1)
- measure
- Change in pain intensity score (where 0 is worst and 10 is best) as measured on the Numeric Rating Scale (NRS) from baseline to Day 36
- timeFrame
- Between Visit 1 (day 1) and the last visit (day 29 ± 7: from day 22 to day 36)
Secondary outcomes (5)
- measure
- Change in sleep disturbance
- timeFrame
- between Visit 1 (DAY 1) and the last visit (DAY29 ± 7: from 22 day to 36 day))
- measure
- Breakthrough pain experience
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who are in need OROS hydromorphone to relieve cancer pain Exclusion Criteria: * Patients with serious gastrointestinal diseases that may interfere with oral analgesic effects, such as dysphagia, vomiting, absence of periastalsis, intestinal obstruction, and/or severe strangulation, in which case the absorption and passage of orally-administered medication may be unduly influenced
References
Publications (1)
- DERIVEDPark CK, Kang HW, Oh IJ, Kim YC, Kim YK, Na KJ, Ahn SJ, Kim TO, Choi YJ, Song GA, Lee MK. Once-Daily OROS Hydromorphone for Management of Cancer Pain: an Open-Label, Multi-Center, Non-Interventional Study. J Korean Med Sci. 2016 Dec;31(12):1914-1921. doi: 10.3346/jkms.2016.31.12.1914. PMID 27822929