drugset / Trial / NCT00000425
Toward Better Outcomes in Osteoarthritis
Phase 3
Completed
900 enrolled
Stanford University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study will determine if there is a difference between commonly used nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen (a pain-reliever that does not prevent inflammation) for treating knee pain in osteoarthritis (OA). The two main results we will look at are disease progression according to x-rays and disability over 3.5 years. Study participants with moderate knee OA and knee pain will continue taking their NSAID or stop taking their NSAID and start taking acetaminophen. Every 6 months we will send the participants questionnaires that ask about pain, medication use, and disability. We will take x-rays of the knees at the start of the study and again at the end of the study.
Timeline
- Start
- 1996-07
- Primary completion
- —
- Completion
- 2001-04
Publications
- Background Lane NE, Thompson JM. Management of osteoarthritis in the primary-care setting: an evidence-based approach to treatment. Am J Med. 1997 Dec 29;103(6A):25S-30S. doi: 10.1016/s0002-9343(97)90005-x.
- Background Manek NJ, Lane NE. Osteoarthritis: current concepts in diagnosis and management. Am Fam Physician. 2000 Mar 15;61(6):1795-804.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 4000 mg | — |