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Duloxetine for Lower Back Pain
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: Naproxen + duloxetine
- Group 2: Naproxen + placebo
- 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.
- 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.
Frequently Asked Questions
Am I able to be a participant in this clinical trial?
"The eligibility criteria for this clinical trial necessitate that participants are aged between 18 and 64, as well as suffering from lower back pain. A total of 100 individuals can be enrolled in the study."
What potential hazards may accompany the use of Naproxen and duloxetine in combination?
"Naproxen + duloxetine has been granted approval and is thus evaluated as a 3 on our team's safety scale."
Does the research permit individuals aged 25 and above to participate?
"Based on the trial's requirements, eligible patients must be between 18 and 64 years old."
Is enrollment still accessible to participants in this trial?
"This clinical trial, which was initially posted on June 1st 2023 and last updated May 1st 2023 according to the information presented on clinicaltrials.gov, is not currently seeking participants. Despite this, 346 other medical studies are actively recruiting volunteers at present."
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