drugset / Trial / NCT00784277
A Study to Compare the Frequency of Constipation Symptoms With Tapentadol Immediate Release (IR) Treatment Versus Oxycodone IR Treatment in Patients With End-stage Joint Disease
Phase 3
Completed
597 enrolled
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Grünenthal GmbH · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to compare bowel function/constipation that occurs during tapentadol treatment with that occuring during oxycodone treatment, as measured by the frequency of spontaneous bowel movements per week. The frequency of spontaneous bowel movements will be determined from a Bowel Function Patient Diary completed by the enrolled sujbects.
Timeline
- Start
- 2008-10
- Primary completion
- 2009-07
- Completion
- 2009-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Oxycodone | Other / unclassified | 10 mg | Oral |
| Comparator | Oxycodone | Other / unclassified | 20 mg | Oral |
| Comparator | Oxycodone | Other / unclassified | 60 mg | Oral |
| Subject | Tapentadol | Small molecule | 50 mg | Oral |
| Subject | Tapentadol | Small molecule | 75 mg | Oral |
| Subject | Tapentadol | Small molecule | 100 mg | Oral |
| Subject | Tapentadol | Small molecule | 500 mg | Oral |