None listed
Conditions
Brief 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).
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.
Sponsors
Bioassets Development Corporation
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Exclusion criteria
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.
Outcome results
None listed