A randomised trial of Enbrel (Etanercept) administered epidurally for the treatment of lumbosacral pain (sciatica)
A randomised, double-blind, placebo-controlled, phase 2a trial of ENBREL (Etanercept) administered by the transforaminal epidural route for the treatment of lumbosacral radiculopathy. (BDCISP2ENBREL)
Bioassets Development Corporation
40 participants
Mar 2, 2009
Interventional
Conditions
Summary
This study aims to determine if administering Etanercept via the epidural route, will be more effective than placebo at reducing pain scores associated with lubosacral radiculopathy (Sciatica).
Eligibility
Inclusion Criteria1
- 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.
Exclusion Criteria1
- Body Mass Index (BMI)>35kg.m2, documented history of allergic reaction to any of the study drugs, has clinically significant heart, lung, kidney or liver illness, has significant pain outside the area affected by the sciatica (radiculopathy), has had lumbar or sacral back surgery or plans for surgical intervention while in the study, has a documented history or Rheumatoid Arthritis or Inflammatory Arthritis, has had epidural corticosteroid injections in the back within 2 months of screening.
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Interventions
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.
Locations(1)
View Full Details on ANZCTR
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ACTRN12609000207213