NCT00000425

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 1996

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1996

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2001

Completed
Last Updated

May 3, 2013

Status Verified

April 1, 2013

First QC Date

November 3, 1999

Last Update Submit

April 30, 2013

Conditions

Osteoarthritis

Keywords

OsteoarthritisSkeletal disorderChemotherapyNonsteroidal anti-inflammatory drugs (NSAIDs)ArthroplastyCartilage metabolismHipKneeOutcomes research

Interventions

Nonsteroidal anti-inflammatory drugs (NSAIDs)DRUG
AcetaminophenDRUG

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Knee osteoarthritis
  • Moderate radiographic evidence by Kellgren and Lawrence grade 2-4
  • Knee pain \> 20 on VAS pain scale

You may not qualify if:

  • Bilateral knee replacements
  • Unwillingness to take acetaminophen for pain relief

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Related Publications (2)

  • 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.

    PMID: 9455966BACKGROUND

  • Manek NJ, Lane NE. Osteoarthritis: current concepts in diagnosis and management. Am Fam Physician. 2000 Mar 15;61(6):1795-804.

    PMID: 10750883BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

Anti-Inflammatory Agents, Non-SteroidalAcetaminophen

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Analgesics, Non-NarcoticAnalgesicsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnti-Inflammatory AgentsTherapeutic UsesAntirheumatic AgentsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Nancy Lane, MD

    UCSF, Division of Rheumatology, SFGH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

July 1, 1996

Study Completion

April 1, 2001

Last Updated

May 3, 2013

Record last verified: 2013-04

Locations

US(1)