drugset / Trial / NCT00455520
A Safety and Efficacy Study for Tapentadol (CG5503) Extended Release for Patients With Painful Diabetic Peripheral Neuropathy
Phase 3
Completed
395 enrolled
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Grünenthal GmbH · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of Tapentadol (CG5503) extended release (ER) (base) compared to placebo in patients with moderate to severe pain from diabetic peripheral neuropathy.
Timeline
- Start
- 2007-04
- Primary completion
- 2008-08
- Completion
- 2008-08
Outcome
Met primary endpoint
registry Tapentadol ER vs Placebo; p <0.001; Mean Difference (Final Values) -1.3 (95% CI -1.7 to -0.92); ANCOVA NCT00455520 ↗
Publications
- Afilalo M, Morlion B. Efficacy of tapentadol ER for managing moderate to severe chronic pain. Pain Physician. 2013 Jan;16(1):27-40.
- Schwartz S, Etropolski M, Shapiro DY, Okamoto A, Lange R, Haeussler J, Rauschkolb C. Safety and efficacy of tapentadol ER in patients with painful diabetic peripheral neuropathy: results of a randomized-withdrawal, placebo-controlled trial. Curr Med Res Opin. 2011 Jan;27(1):151-62. doi: 10.1185/03007995.2010.537589.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |