drugset / Trial / NCT01063868
A Long-term Safety Study With Tapentadol ER and Oxycodone CR in Patients With Moderate to Severe Pain Due to Chronic, Painful Diabetic Peripheral Neuropathy (DPN)
Phase 3
Terminated
47 enrolled
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Grünenthal GmbH · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety profile of orally administered tapentadol ER dosages of 100 to 250 mg twice daily in patients with chronic, painful diabetic peripheral neuropathy (DPN) over long-term exposure of up to 1 year.
Timeline
- Start
- 2010-01
- Primary completion
- 2010-04
- Completion
- 2010-06
Outcome
Outcome not reported
Stopped (Business): “Business decision”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Oxycodone | Other / unclassified | 20 mg | Oral |
| Comparator | Oxycodone | Other / unclassified | 30 mg | Oral |
| Comparator | Oxycodone | Other / unclassified | 40 mg | Oral |
| Comparator | Oxycodone | Other / unclassified | 50 mg | Oral |
| Subject | Tapentadol | Small molecule | 100 mg | Oral |
| Subject | Tapentadol | Small molecule | 150 mg | Oral |
| Subject | Tapentadol | Small molecule | 200 mg | Oral |
| Subject | Tapentadol | Small molecule | 250 mg | Oral |