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Nonsteroidal Anti-Inflammatory Drug

Pain Medication for Knee Osteoarthritis (PREDICT Trial)

Phase 4

Recruiting

Led By Thomas J Schnitzer, MD, PhD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must be able to return for all clinic visits

Must be able to speak English and be willing to read and understand instructions as well as questionnaires

Must not have

High dose opioid prophylaxis, as defined as > 50mg morphine equivalent/day

Chronic neurologic conditions, e.g., Parkinson's

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to end of first treatment period (week 6) and second treatment period (week 16)

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is for people with knee osteoarthritis pain at Northwestern University. It will last about 20 weeks and involve 180 participants. Participants will be split into three groups and given either dul

Who is the study for?

This trial is for individuals with knee pain from osteoarthritis. Participants will undergo various tests including X-rays, MRIs, and questionnaires at Northwestern University over approximately 20 weeks. Key requirements include having knee osteoarthritis and being able to complete the study activities.

What is being tested?

The study compares the effectiveness of two medications, Celecoxib and Duloxetine, against a placebo in managing knee osteoarthritis pain. It aims to predict who will benefit from these treatments based on brain-based and clinical assessments.

What are the potential side effects?

Celecoxib may cause digestive issues, cardiovascular risks or kidney problems; Duloxetine can lead to nausea, dry mouth, sleepiness or dizziness. Placebos typically have no active ingredients but can still result in perceived side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can attend all required clinic visits.

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I can speak English and understand written instructions.

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I have had knee pain most days in the last month.

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I have been diagnosed with knee osteoarthritis according to ACR criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking more than 50mg of morphine or its equivalent daily for pain.

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I have a long-term neurological condition like Parkinson's.

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I do not have major health issues like uncontrolled high blood pressure, unstable diabetes, severe heart or liver disease.

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My kidney function is reduced (high creatine levels).

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I have been diagnosed with an inflammatory joint condition.

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I have long-term kidney problems.

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I am allergic to sulfonamide drugs, duloxetine, or acetaminophen.

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I have had a peptic ulcer or bleeding in my stomach/intestines before.

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I am taking blood thinners other than low-dose aspirin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to end of first treatment period (week 6) and second treatment period (week 16)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to end of first treatment period (week 6) and second treatment period (week 16)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to end of first treatment period (week 6) and second treatment period (week 16) for reporting.