drugset / Trial / NCT00505414
A Study to Evaluate the Effectiveness and Safety of CG5503 (Tapentadol) in the Treatment of Chronic Tumor Related Pain Compared With Placebo and Morphine
Phase 3
Terminated
136 enrolled
Grünenthal GmbH
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to determine whether CG5503 (tapentadol) is effective and safe in the treatment of chronic tumor related pain compared to placebo.
Timeline
- Start
- 2007-06
- Primary completion
- 2009-02
- Completion
- 2009-05
Outcome
Outcome not reported
Stopped: “Recall of rescue medication, alternative rescue medication availability issues.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Morphine | Other / unclassified | 45 mg | Oral |
| Comparator | Morphine | Other / unclassified | 90 mg | Oral |
| Subject | Tapentadol | Small molecule | 100 mg | Oral |
| Subject | Tapentadol | Small molecule | 250 mg | Oral |