drugset / Trial / NCT00472303
A Study to Evaluate Tapentadol (CG5503) in the Treatment of Chronic Tumor-Related Pain Compared With Placebo and Morphine
Phase 3
Completed
622 enrolled
Grünenthal GmbH
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study will be to determine whether tapentadol (CG5503) is effective and safe in the treatment of chronic tumor related pain compared to placebo. In addition tapentadol (CG5503) will also be compared to morphine controlled release, also referred to as slow release (SR). \*Tapentadol prolonged-release (PR) is the term used in the European Union and is referred to as extended release (ER) in the United States.
Timeline
- Start
- 2007-07
- Primary completion
- 2012-06
- Completion
- 2012-06
Publications
- Results Kress HG, Koch ED, Kosturski H, Steup A, Karcher K, Lange B, Dogan C, Etropolski MS, Eerdekens M. Tapentadol prolonged release for managing moderate to severe, chronic malignant tumor-related pain. Pain Physician. 2014 Jul-Aug;17(4):329-43.
- Results Kress HG, Koch ED, Kosturski H, Steup A, Karcher K, Dogan C, Etropolski M, Eerdekens M. Direct conversion from tramadol to tapentadol prolonged release for moderate to severe, chronic malignant tumour-related pain. Eur J Pain. 2016 Oct;20(9):1513-8. doi: 10.1002/ejp.875. Epub 2016 Apr 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Morphine | Other / unclassified | 40 mg | Oral |
| Comparator | Morphine | Other / unclassified | 100 mg | Oral |
| Subject | Tapentadol | Small molecule | 100 mg | Oral |
| Subject | Tapentadol | Small molecule | 250 mg | Oral |