Overview

Toward Better Outcomes in Osteoarthritis

Status:
Completed
Trial end date:
2001-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Stanford University
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Treatments:
Acetaminophen
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Criteria
Inclusion Criteria:

- Knee osteoarthritis

- Moderate radiographic evidence by Kellgren and Lawrence grade 2-4

- Knee pain > 20 on VAS pain scale

Exclusion Criteria:

- Bilateral knee replacements

- Unwillingness to take acetaminophen for pain relief