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Duloxetine for LBP

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Primary and study completion dates: May 2026 to May 2027v6
  2. Primary endpoints: 3 to 1
    • Primary and study completion dates: Sep 2026 to May 2026
    • Eligibility criteria expanded, about 32 words
    • Secondary endpoints: 1 to 5
    v5
  3. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Aug 2026 to Sep 2026
    • Study completion date: Nov 2026 to Sep 2026
    • Start date changed from estimate of Oct 2023 to Oct 4, 2023
    • Site details revised
  4. Start date: Aug 2023 to Oct 2023
    • Primary completion date: Jun 2026 to Aug 2026
    • Study completion date: Sep 2026 to Nov 2026
    v3
  5. Start date: Jun 2023 to Aug 2023
    • Enrollment target: 100 to 120
    • Primary completion date: May 2026 to Jun 2026
    • Study completion date: Aug 2026 to Sep 2026
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05851976
Lead Sponsor Montefiore Medical Center
Conditions
(from sponsor)		 Back Pain, Low
Related terms Low Back Pain
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov