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

Phase 2

Completed

• Conditions: Sciatic pain; Anaesthesiology - Pain management

• Registration Number: ACTRN12609000207213
• Lead Sponsor: Bioassets Development Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[From time of consent, safety will be assessed at each study visit and where necessary between study visits, until the final follow-up visit at Week 28. There are 8 study visits scheduled over 28 weeks with Visit 1 (week -1), Visit 2 (Day 0), Visit 3 (Week 2), Visit 4 (Week 4), Visit 5 (Week 6), Visit 6 (Week 10), Visit 7 (Week 14), Visit 8 (Week 28).]

Secondary Outcome Measures

Name	Time	Method
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[From first dose to 6 months post dose, pain will be assessed by means of patient diary cards, completed for daily prior to the study visits. Study visits are completed at Visit 1 (week -1), Visit 2 (Day 0), Visit 3 (Week 2), Visit 4 (Week 4), Visit 5 (Week 6), Visit 6 (Week 10), Visit 7 (Week 14), Visit 8 (Week 28).]