A randomised trial of Enbrel (Etanercept) administered epidurally for the treatment of lumbosacral pain (sciatica)

Category Primary study
Registry of TrialsANZCTR
Year 2009
INTERVENTION: Patients will be assigned to 1 of 3 dose levels of Etanercept (0.5mg, 2.5mg or 12.5mg), which will be administered twice, 2 weeks apart via the epidural route. CONDITION: Sciatic pain PRIMARY OUTCOME: to evaluate the safety of three different doses of Etanercept versus placebo when administered epidurally. Safety will be assessed by the monitoring of adverse event information, physical examination, clinical laboratory tests and vital signs measurement. SECONDARY OUTCOME: To evaluate the efficacy of three different doses of Etanercept versus placebo when administered epidurally for the treatment of lumbosacral pain by assessment of reduction in patient pain scores INCLUSION CRITERIA: Healthy males or females with primary diagnosis of sciatica (lumbosacral radiculopathy) of between 6 and 26 weeks duration. Must have negative tuberculin skin test. Sciatica must been confirmed by Magnetic Resonance Imaging (MRI), have positive straight leg raise at screening or positive femoral stretch test.
Epistemonikos ID: f671a1f4ffaecc7b1f3dc395b62df0b7564c7219
First added on: Aug 22, 2024