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Trial registered on ANZCTR


Registration number
ACTRN12609000207213
Ethics application status
Approved
Date submitted
28/01/2009
Date registered
24/04/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised trial of Enbrel (Etanercept) administered epidurally for the treatment of lumbosacral pain (sciatica)
Scientific title
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)
Secondary ID [1] 260102 0
BDCISP2ENBREL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sciatic pain 4242 0
Condition category
Condition code
Anaesthesiology 4464 4464 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 3966 0
Treatment: Drugs
Comparator / control treatment
2mL of normal saline, administered twice, two weeks apart via the epidural route
Control group
Placebo

Outcomes
Primary outcome [1] 5346 0
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.
Timepoint [1] 5346 0
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 [1] 8983 0
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
Timepoint [1] 8983 0
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).

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Centralised randomisation procedures to be used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created using a computer program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Three doses of Etanercept will be assessed. Patients will be randomised to the different dosing groups.
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1404 0
5000
Recruitment postcode(s) [2] 1405 0
6009
Recruitment postcode(s) [3] 1629 0
3144
Recruitment postcode(s) [4] 2370 0
6160
Recruitment postcode(s) [5] 2371 0
3162
Recruitment postcode(s) [6] 2372 0
2305

Funding & Sponsors
Funding source category [1] 4424 0
Commercial sector/Industry
Name [1] 4424 0
Bioassets Development Corporation
Address [1] 4424 0
888 Worcester Street, Suite 95
Wellesley MA 02482
Country [1] 4424 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Bioassets Development Corporation
Address
888 Worcester Street, Suite 95
Wellesley MA 02482
Country
United States of America
Secondary sponsor category [1] 3984 0
Commercial sector/Industry
Name [1] 3984 0
CMAX - a division of IDT Australia Limited
Address [1] 3984 0
274 Melbourne Street
North Adelaide SA 5006
Country [1] 3984 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6473 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 6473 0
North Terrace
Adelaide SA 5000
Ethics committee country [1] 6473 0
Australia
Date submitted for ethics approval [1] 6473 0
Approval date [1] 6473 0
23/12/2008
Ethics approval number [1] 6473 0
081110
Ethics committee name [2] 6914 0
Cabrini Human Research Ethics Committee
Ethics committee address [2] 6914 0
183 Wattletree Road, Malvern VIC 3144
Ethics committee country [2] 6914 0
Australia
Date submitted for ethics approval [2] 6914 0
12/02/2009
Approval date [2] 6914 0
31/03/2009
Ethics approval number [2] 6914 0
07-02-03-09
Ethics committee name [3] 239570 0
Sir Charles Gairdner Hospital Human Research Ethics Committee
Ethics committee address [3] 239570 0
Hospital Avenue, Nedlands WA 6009
Ethics committee country [3] 239570 0
Australia
Date submitted for ethics approval [3] 239570 0
Approval date [3] 239570 0
14/05/2009
Ethics approval number [3] 239570 0
2009-013
Ethics committee name [4] 239571 0
Southern Metropolitan Area Health Service Human Research Ethics Committee
Ethics committee address [4] 239571 0
Fremantle Hospital
Alma Street, Fremantle WA
Ethics committee country [4] 239571 0
Australia
Date submitted for ethics approval [4] 239571 0
Approval date [4] 239571 0
07/07/2009
Ethics approval number [4] 239571 0
09/119
Ethics committee name [5] 239572 0
Bellberry Human Research Ethics Committee
Ethics committee address [5] 239572 0
229 Greenhill Road, Dulwich, SA 5065
Ethics committee country [5] 239572 0
Australia
Date submitted for ethics approval [5] 239572 0
01/07/2009
Approval date [5] 239572 0
Ethics approval number [5] 239572 0
B101/09
Ethics committee name [6] 258308 0
Hunter New England Human Research Ethics Committee
Ethics committee address [6] 258308 0
John Hunter Hospital
Lookout Road
New Lambton, NSW
Ethics committee country [6] 258308 0
Australia
Date submitted for ethics approval [6] 258308 0
Approval date [6] 258308 0
18/11/2009
Ethics approval number [6] 258308 0
HREC/09/HNE/281

Summary
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).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29224 0
Address 29224 0
Country 29224 0
Phone 29224 0
Fax 29224 0
Email 29224 0
Contact person for public queries
Name 12471 0
Kate Beard
Address 12471 0
CMAX
274 Melbourne St
North Adelaide SA 5006
Country 12471 0
Australia
Phone 12471 0
+61 8 8416 3100
Fax 12471 0
+61 8 8361 8615
Email 12471 0
kate.beard@cmax.com.au
Contact person for scientific queries
Name 3399 0
Professor Guy Ludbrook, Principal Investigator
Address 3399 0
Department of Anaesthesia and Intensive Care,
Level 5, Eleanor Harrald Building
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 3399 0
Australia
Phone 3399 0
+61 8 8222 5422
Fax 3399 0
+61 8 8222 5887
Email 3399 0
guy.ludbrook@adelaide.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary