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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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with Moderate or severe pain
Secondary outcome measures
Number of Participants demonstrating improvement based on Roland Morris Disability Questionnaire results
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
446 Previous Clinical Trials
582,654 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My back pain significantly affects my daily activities.My pain has lasted less than 2 weeks.My pain is not due to nerve damage.I don't have alcohol issues, liver or kidney disease, glaucoma, depression medication use, severe depression or suicidal thoughts.I do not have allergies to NSAIDs, stomach ulcers, severe heart failure, uncontrolled high blood pressure, kidney issues, use blood thinners, or have liver disease.My lower back pain is due to muscle or bone issues, not injury or nerve problems.I have had moderate or severe pain most days for the last three months.I went to the ER mainly for lower back pain, not including pain on the sides of my body.I am between 18 and 64 years old.I experienced back pain less than once a week before my recent severe episode.
Research Study Groups:
This trial has the following groups:- Group 1: Naproxen + duloxetine
- Group 2: Naproxen + placebo
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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