Phase 4
N=141
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
Bottom Line
View on ClinicalTrials.gov: NCT01006356 ↗Enrolled (actual)
141
Serious AEs
30.8%
Results posted
Aug 2013
Primary outcome: Primary: Percentage of Participants With Dosing Frequency of Analgesics for Treating Breakthrough Pain — 50.9 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Hydromorphone HCl OROS (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Janssen Korea, Ltd., Korea
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Dosing Frequency of Analgesics for Treating Breakthrough Pain |
50.9 | — |
| SECONDARY Frequency of Experiencing Breakthrough Pain |
1.1; 0.8; 1.8; 1.2; 1.0; 0.6 | — |
| SECONDARY Change From Baseline in Korean - Brief Pain Inventory (K-BPI) Score at Day 15 |
3.66; 0.359 | — |
| SECONDARY Pain Intensity Score |
3.7; 3.6; 3.3; 3.3 | — |
| SECONDARY Global Assessment of Overall Efficacy of Study Drug by Investigator |
4; 37; 48; 12; 3 | — |
| SECONDARY Global Assessment of Overall Efficacy of Study Drug by Participant |
9; 31; 49; 12; 3 | — |
| SECONDARY Participant's Preferences Along With Reasons |
33; 1; 3; 74; 29; 2 | — |
| SECONDARY Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score |
3; 23; 45; 30; 1; 2 | — |
| SECONDARY European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score |
3.00; 3.07; 2.98; 3.18; 1.98; 2.22 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01006356). 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.