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A Randomized, Open-Labeled, Multi-Center Study to Investigate the Safety and Efficacy of OROS Hydromorphone HCl Comparing With Morphine SR in Cancer Pain Patients
The purpose of this study is to evaluate the effectiveness and safety of Osmotic Release Oral System (OROS) hydromorohone Hydrochloride (HCl) compared with morphine sustain release (SR) in participants with chronic (lasting a long time) malignant (cancerous) cancer pain.
Details
| Lead sponsor | Johnson & Johnson Taiwan Ltd |
|---|---|
| Phase | Phase 3 |
| Status | TERMINATED |
| Enrolment | 2 |
| Start date | 2008-11 |
| Completion | 2008-12 |
Conditions
- Cancer Pain
Interventions
- Hydromprphone Hydrochloride (HCl) OROS
- Morphine Sustain Release (SR)
Primary outcomes
- Brief Pain Inventory (BPI) Questionnaire Item 3 "Worst Pain" Score at Day 14 — Day 14
The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI Questionnaire Item 3 "Worst Pain" will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine). - BPI Questionnaire Item 3 "Worst Pain" Score at Day 28 — Day 28
The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item 3 "Worst Pain" will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).