drugset / Trial / NCT01309386
A Safety and Efficacy Study of Oral Tapentadol Extended-Release in Japanese Participants
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the conversion rate based on the number of participants achieving pain control and safety within 1 week after switching the opioid (morphine-like medications) analgesics (drug used to control pain), when tapentadol extended-release (ER) (JNS024ER) is orally administered to participants treated with around-the-clock opioid analgesics, for their moderate to severe (very serious, life threatening) chronic (lasting a long time) malignant (cancerous) tumor-related (a mass in a specific area) cancer (abnormal tissue that grows and spreads in the body) pain.
Timeline
- Start
- 2010-08
- Primary completion
- 2012-01
- Completion
- 2012-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Morphine SR | Unknown | 30 mg | Oral |
| Comparator | Morphine SR | Unknown | 120 mg | Oral |
| Comparator | Morphine SR | Unknown | 140 mg | Oral |
| Subject | Tapentadol ER | Unknown | 100 mg | Oral |
| Subject | Tapentadol ER | Unknown | 400 mg | Oral |
| Subject | Tapentadol ER | Unknown | 500 mg | Oral |