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Serotonin-Norepinephrine Reuptake Inhibitor

Duloxetine for Lower Back Pain

Phase 4
Recruiting
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Functionally impairing back pain: A baseline score of > 5 on the Roland-Morris Disability Questionnaire
Pain duration <2 weeks (336 hours).
Must not have
Contra-indication to duloxetine: alcohol use disorder, chronic liver disease, chronic kidney disease, glaucoma, Active use of medication for depression, Score >4 on the Patient Health Questionnaire (PHQ-9) screening instrument or thoughts of suicide
Chronic pain syndrome defined as moderate or severe pain anywhere in their body on >50% of days for at least three months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial will investigate if a drug can reduce chronic back pain. Patients with acute low back pain will be studied to see if duloxetine can help prevent it from lasting 3 months.

Who is the study for?
This trial is for adults aged 18-64 with recent non-radicular lower back pain that's bad enough to affect their daily life. They must not be pregnant, breastfeeding, or have allergies to the study medications. People with chronic liver or kidney disease, glaucoma, depression medication use, high suicide risk, chronic pain syndromes, severe heart failure or uncontrolled blood pressure are excluded.
What is being tested?
The study is testing if duloxetine can prevent long-term low back pain in patients who come to the ER with acute symptoms. Participants will receive either naproxen (a common anti-inflammatory drug) or duloxetine (usually used for depression and nerve pain) to see which one helps more.
What are the potential side effects?
Duloxetine may cause nausea, dry mouth, sleepiness, constipation and increased sweating. Naproxen might lead to stomach upset/pain, heartburn, headache and dizziness. Serious side effects could include liver damage from duloxetine and heart attack/stroke risks from naproxen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My back pain significantly affects my daily activities.
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My pain has lasted less than 2 weeks.
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My pain is not due to nerve damage.
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My lower back pain is due to muscle or bone issues, not injury or nerve problems.
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I went to the ER mainly for lower back pain, not including pain on the sides of my body.
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I am between 18 and 64 years old.
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I experienced back pain less than once a week before my recent severe episode.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I don't have alcohol issues, liver or kidney disease, glaucoma, depression medication use, severe depression or suicidal thoughts.
Select...
I have had moderate or severe pain most days for the last three months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with Moderate or severe pain
Secondary study objectives
Number of Participants demonstrating improvement based on Roland Morris Disability Questionnaire results

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Naproxen + duloxetineExperimental Treatment2 Interventions
Group II: Naproxen + placeboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naproxen
2019
Completed Phase 4
~31530
Duloxetine
2011
Completed Phase 4
~4170

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor
456 Previous Clinical Trials
588,350 Total Patients Enrolled

Media Library

Duloxetine (Serotonin-Norepinephrine Reuptake Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05851976 — Phase 4
Lower Back Pain Research Study Groups: Naproxen + duloxetine, Naproxen + placebo
Lower Back Pain Clinical Trial 2023: Duloxetine Highlights & Side Effects. Trial Name: NCT05851976 — Phase 4
Duloxetine (Serotonin-Norepinephrine Reuptake Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05851976 — Phase 4
~74 spots leftby Sep 2026
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