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Duloxetine Metabolism and Fibromyalgia

Study acronym: DILIGENT
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later May 1, 2026 → May 1, 2027
See other at-risk trials from University of Utah

Record History

  1. Primary and study completion pushed from May 1, 2026 to May 1, 2027 Eligibility criteria expanded, about 7 words · Secondary endpoints: details revised at 1 of 6 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 1 of 6 entries
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruiting Primary and study completion dates: Feb 1, 2026 to May 1, 2026 · Start date changed from estimate of Mar 2025 to May 1, 2025 · Site details revisedv2 Show 3 more changesShow less
    • Primary and study completion dates: Feb 1, 2026 to May 1, 2026
    • Start date changed from estimate of Mar 2025 to May 1, 2025
    • Site details revised
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
People with fibromyalgia report generalized body pain ("pain all over"), increased sensitivity to painful stimulation, chronic tiredness or low energy, sleep problems, and other physical and functional problems. The exact cause of the disorder is poorly understood, and treatment can be difficult. The degree to which duloxetine is helpful for people with fibromyalgia varies greatly. For some people, it is very helpful for managing fibromyalgia symptoms. For others, people may not notice any benefit. Yet for some, it is a little helpful and the effect is noticeable only when people forget to take the medicine. The purpose of this study is to collect data to better understand the relationship among gene types that control those enzymes, blood concentrations of duloxetine, and how it helps the symptoms.
Trial Details
NCT Number NCT06866444
Lead Sponsor University of Utah
Conditions Fibromyalgia, Duloxetine
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov