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Nonsteroidal Anti-Inflammatory Drug

Duloxetine for 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

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

PREDICT Trial 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.Check my eligibility

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.See study design

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.

PREDICT Trial 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.

PREDICT Trial 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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

"Responders" to treatment

PREDICT Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: DuloxetineActive Control1 Intervention

Duloxetine 60mg tablet, daily (with an initial and final 7-day titration at 30 mg, daily)

Group II: CelecoxibActive Control1 Intervention

Celecoxib 200 mg tablet, daily

Group III: PlaceboPlacebo Group1 Intervention

Matching placebo tablet, daily

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,589 Previous Clinical Trials

916,946 Total Patients Enrolled

13 Trials studying Osteoarthritis

712 Patients Enrolled for Osteoarthritis

Brigham and Women's HospitalOTHER

1,616 Previous Clinical Trials

11,470,770 Total Patients Enrolled

16 Trials studying Osteoarthritis

29,693 Patients Enrolled for Osteoarthritis

Thomas J Schnitzer, MD, PhDPrincipal InvestigatorNorthwestern University

10 Previous Clinical Trials

330 Total Patients Enrolled

2 Trials studying Osteoarthritis

60 Patients Enrolled for Osteoarthritis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants involved in this clinical investigation?

"Indeed, the details on clinicaltrials.gov affirm that this investigation is actively pursuing volunteers. The trial was originally listed on January 31st, 2024 and last revised on February 5th, 2024. Specifically, they are seeking to enroll 180 participants at a singular site."

Answered by AI

What are the potential risks associated with Celecoxib use in individuals?

"Based on our evaluation at Power, Celecoxib's safety is rated as 3 due to it being part of a Phase 4 trial, signifying its approval for use."

Answered by AI

Are there any ongoing efforts to enroll participants for this study?

"Indeed, information on clinicaltrials.gov indicates that this research endeavor is currently in the process of enrolling participants. The trial was initially listed on January 31st, 2024 and last revised on February 5th, 2024. A total of 180 patients are being sought at a single site."

Answered by AI