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Nonsteroidal Anti-inflammatory Drug (NSAID)

Ibuprofen + Dexamethasone for Lower Back Pain

Phase 4

Recruiting

Led By Eddie Irizarry, MD

Research Sponsored by Montefiore Medical Center

Eligibility Criteria Checklist

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

Must have

Pain duration <2 week

Age 18-70 Enrollment will be limited to adults <70 years because of the increased risk of adverse medication effects in older adults.

Must not have

Contra-indications to investigational medications: 1) known peptic ulcer disease, chronic dyspepsia, or history of gastrointestinal bleed 2) Severe heart failure (NYHA 2 or worse) 3) Chronic kidney disease (GFR <60ml/min) 4) Current use of anti-coagulants 5) cirrhosis (Child Pugh A or worse) or hepatitis (transaminases 2x the upper limit of normal)

Chronic pain syndrome defined as use of any analgesic medication on a daily or near-daily basis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 days (48 hours)

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial studies how well a 2-day dose of dexamethasone and ibuprofen help patients with acute low back pain. Patients will get a low back pain education session too.

Who is the study for?

This trial is for adults aged 18-70 with acute radicular low back pain, which hasn't lasted more than two weeks and radiates from the lower back to the leg. Participants should have a significant level of disability due to their pain but can't have had frequent back pain in the past three months or direct trauma recently. They must not be pregnant, suffer from chronic pain syndromes, or have conditions that make ibuprofen or dexamethasone risky.

What is being tested?

The study tests if adding dexamethasone to standard care (ibuprofen and education on low back pain) helps improve outcomes for acute radicular low back pain when given during an emergency department visit. Patients are randomly assigned to receive either dexamethasone or a placebo alongside ibuprofen, without knowing which one they're getting.

What are the potential side effects?

Possible side effects include stomach issues like ulcers and bleeding for ibuprofen; while dexamethasone may cause mood changes, increased blood sugar levels, insomnia, and weakened immunity among others.

Eligibility Criteria

Inclusion Criteria

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

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My pain has lasted less than 2 weeks.

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I am between 18 and 70 years old.

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My back pain severely affects my daily activities.

Exclusion Criteria

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

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You will be excluded from the study if you have: 1) Stomach ulcers, ongoing stomach discomfort, or history of stomach bleeding 2) Severe heart failure 3) Chronic kidney disease 4) Taking anti-coagulants 5) Liver disease or hepatitis with specific liver enzyme levels.

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I take pain medication almost every day for chronic pain.

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I regularly use steroids for a long-term condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 days (48 hours)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 days (48 hours)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 days (48 hours) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Roland Morris Disability Questionnaire (RMDQ) score

Secondary study objectives

Absolute Roland Morris Disability Questionnaire (RMDQ) score

Analgesic or LBP medication within the previous 24 hours

Frequency of Radicular LBP

+4 more

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: Ibuprofen + dexamethasone + educational interventionExperimental Treatment3 Interventions

Ibuprofen 400 mg PO every 8 hours as needed for 7 days + dexamethasone 16 mg PO for day 1 and day 2. Research personnel will provide each participant with a 15-minute educational intervention.

Group II: Ibuprofen + placebo + educational interventionPlacebo Group2 Interventions

Ibuprofen 400 mg PO every 8 hours as needed for 7 days + placebo PO for day 1 and day 2. Research personnel will provide each participant with a 15-minute educational intervention.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ibuprofen 400 mg

2021

Completed Phase 4

~2000

Dexamethasone Oral

2020

N/A

~14110