85 Participants NeededMy employer runs this trial

Duloxetine for Osteoarthritis

(PACE-UP Trial)

BA
ER
Overseen ByEmma Racunas, BS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to examine the effects of duloxetine on walking ability and physical activity in patients with knee osteoarthritis. Researchers will compare duloxetine to a placebo (a look-alike substance that contains no drug) to see if duloxetine works to improve walking ability in patients with knee osteoarthritis. At study visits, participants will complete surveys, perform physical function tasks, undergo non-invasive brain imaging, and undergo sensory testing.

Who Is on the Research Team?

BA

Benedict Alter, MD, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for adults with knee osteoarthritis who have ongoing knee pain. Participants should be able to walk and take part in physical tests. People with certain medical or psychiatric conditions, or those taking medications that could interfere with the study, may not be eligible.

Inclusion Criteria

Only English-speaking subjects included
I have had knee pain for more than 6 months.
I am eligible regardless of my gender.
See 3 more

Exclusion Criteria

I have had a steroid or other injection in my knee within the last month.
I have inflammatory arthritis like rheumatoid arthritis.
I have had knee radiofrequency ablation in the past 3 months.
See 19 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a double-blind, cross-over treatment with duloxetine and placebo over 16 weeks

16 weeks
Several visits for assessments and measurements

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Duloxetine

Trial Overview

The study compares duloxetine (a medication often used for pain and depression) to a placebo to see if it helps people with knee osteoarthritis walk better and be more active. Participants are randomly assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Placebo, then duloxetineExperimental Treatment2 Interventions
Group II: Duloxetine, then placeboExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Benedict Alter

Lead Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+