Clinical trial · Interventional
An Efficacy and Safety Study of Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS) in the Reduction of Breakthrough Pain Medication Frequency in Participants With Cancer
Cancer Pain Management With Hydromorphone HCl ORal Osmotic System in Korean Cancer Patient: Evaluation of Its Clinical Usefulness in Reduction of Breakthrough Pain Medication Frequency
NCT01006356CI-TRIAL-00011667completedPhase 4Results postedClinicalTrials.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)
The purpose of this study is to evaluate the clinical efficacy of hydromorphone hydrochloride (HCl) Oral Osmotic System (OROS) by assessing the extent of reduction of medication frequency for the management of breakthrough pain after the administration of hydromorphone HCl OROS in Korean cancer participants.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hydromorphone HCl OROS | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hydromorphone hydrochloride (HCl) oral osmotic system (OROS)
- description
- Hydromorphone HCl OROS 8 milligram (mg) once daily for 2 weeks.
- interventionNames
- Drug: Hydromorphone HCl OROS
Primary outcomes (1)
- measure
- Percentage of Participants With Dosing Frequency of Analgesics for Treating Breakthrough Pain
- timeFrame
- Day 15
- description
- Percentage of participants with decrease in dosing frequency by 33 percent or more in breakthrough pain (acute pain that comes on rapidly despite the use of pain medication) was determined at final visit (Day 15) compared to Baseline (Day 1 - when the administration of study drug was started).
Secondary outcomes (8)
- measure
- Frequency of Experiencing Breakthrough Pain
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Cancer participants administering only strong oral opioid analgesic for cancer pain control * Participants administering short-acting narcotic analgesics at least twice daily due to breakthrough pain for 3 days just before Visit 2 (Day 1) * Participants sufficiently capable of complying overall study requirements including participant diary for pain at the discretion of the Investigators * Abstinent or surgically sterile female participants Exclusion Criteria: * Participants with cancer pain who are potentially unresponsive to narcotic analgesics * Participants with presence or history of drug or alcohol abuse within the past 6 months * Participants with hypersensitivity to hydromorphone HCl * Participants with history of colectomy (surgery to remove part or all of the colon) * Participants with severe digestive tract disease which might interfere with oral analgesic effects, such as dysphagia (trouble swallowing), vomiting, no bowel movement, ileus, and severe enterostenosis that can influence absorption and passing through of oral medication
References
Publications (0)
Data not yet available
No reference posted for this study.