Duloxetine for LBP

Part of paid clinical trials in The Bronx, New York.

Sponsor
Montefiore Medical Center
Study ID
NCT05851976
Phase
PHASE4
Status
Recruiting
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Conditions

  • Back Pain, Low

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Naproxen — DRUG
    Naproxen 500mg twice daily for 16 days
  • Duloxetine — DRUG
    Duloxetine 60mg daily for 14 days

Study Details

This research study will help determine whether a medication called duloxetine can improve back pain. It is well documented that many participants who come to the ER with acute low back pain still have low back pain 3 months later. The investigator team will attempt to determine whether duloxetine can help prevent this.

Key Dates

Start date
Oct 4, 2023
Status verified
Dec 2025
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Naproxen + duloxetine
  • Placebo Comparator: Naproxen + placebo

Primary Outcome Measure

Number of participants with moderate or severe Low Back Pain (LBP) [ Time Frame: 16 days, 42 days and 84 days after ED discharge ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Montefiore Medical CenterThe BronxNew York10467
Benjamin W Friedman, MD
[email protected]
718-920-6626

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By research site
Montefiore Medical Center· The Bronx, NY

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