An Efficacy, Safety and Effects on Quality of Life of Tramadol/Paracetamol as Add-on Therapy in Chronic Osteoarthritis
Summary
The purpose of this study is to evaluate the efficacy, safety and effects on Quality of Life (QOL) of tramadol/paracetamol (APAP) as an add-on therapy (medication taken in addition to another medication) in Filipino participants with chronic (lasting a long time) osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stiff).
Timeline
- Start
- 2007-10
- Primary completion
- 2008-05
- Completion
- 2008-05
Outcome
Met primary endpoint
registry MEAN Tramadol/Paracetamol (APAP): Change at Week 2: -29.721 (Standard Deviation 16.936) mm NCT01728246 ↗
registry MEAN Non-Tramadol/APAP: Change at Week 2: -21.972 (Standard Deviation 12.906) mm NCT01728246 ↗
registry analysis (superiority or other test); Tramadol/Paracetamol (APAP) vs Non-Tramadol/APAP; p <0.05; t-test, 2 sided NCT01728246 ↗
registry MEAN Tramadol/Paracetamol (APAP): -45.027 (Standard Deviation 19.963) mm NCT01728246 ↗
registry MEAN Non-Tramadol/APAP: -34.266 (Standard Deviation 15.665) mm NCT01728246 ↗
registry MEAN Tramadol/Paracetamol (APAP): Change at Week 4 (LOCF): -19.102 (Standard Deviation 15.103) units on a scale NCT01728246 ↗
registry MEAN Non-Tramadol/APAP: Change at Week 4 (LOCF): -15.177 (Standard Deviation 13.328) units on a scale NCT01728246 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 325 mg | — |
| Subject | Tramadol | Other / unclassified | 37.5 mg | — |
| Background | Celecoxib | Other / unclassified | 200 mg | — |