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Lumbar Spinal Fibrosis and TNF Alpha Inhibition

StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Publications: details revised at 1 of 1 entry Collaborators expanded, about 5 wordsv6 Show all 2 changesShow less
    • Collaborators expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  2. Notable Study completion date changed from estimate of Jun 2013 to Dec 2014 Trial status: Active, Not Recruiting to Completed · Enrollment target: estimated 40 to confirmed 38v5 Show all 3 changesShow less
    • Trial status: Active, Not Recruiting to Completed
    • Enrollment target: estimated 40 to confirmed 38
  3. Minor Primary completion date changed from estimate of Sep 2012 to Oct 2012 Completion date: Jan 2013 to Jun 2013v4 Show all 2 changesShow less
    • Completion date: Jan 2013 to Jun 2013
  4. Minor Trial status: Recruiting to Active, Not Recruiting Primary completion date: Sep 2012 · Completion date: Nov 2008 to Jan 2013 · Interventions: TNF blocker (Drug) to Placebo (Drug), TNF blocker (Drug) · 3 morev3 Show all 7 changesShow less
    • Primary completion date: Sep 2012
    • Completion date: Nov 2008 to Jan 2013
    • Interventions: TNF blocker (Drug) to Placebo (Drug), TNF blocker (Drug)
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised
    • Study arms: 0 to 2
  5. Notable Trial status: Not Yet Recruiting to Recruiting Start date: Nov 2006 to Feb 2007 · Site details revisedv2 Show all 3 changesShow less
    • Start date: Nov 2006 to Feb 2007
    • Site details revised
  6. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
TNF-alpha is the main cytokine implicated in the formation of lumbar spinal fibrosis. Inhibiting TNF-alpha could significantly decrease spinal fibrosis after lumbar discectomy.
Trial Details
NCT Number NCT00385086
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators: URC-CIC Paris Descartes Necker Cochin
Conditions Post Operative Sciatica by Lumbar Spinal Fibrosis
Enrollment 38 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov