EUCTR2009-012836-33-DE
Active, Not Recruiting
N/A
A randomised, double blind study to evaluate the safety and efficacy of the p38 kinase inhibitor, GW856553, in subjects with neuropathic pain from lumbosacral radiculopathy
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- europathic pain from lumbosacral radiculopathy
- Sponsor
- GlaxoSmithKline Research & Development Limited
- Enrollment
- 142
- Status
- Active, Not Recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female subjects aged 18 – 80 years inclusive, at the time of signing the
- •informed consent.
- •2\. A female subject is eligible to participate if she is of:
- •Non\-childbearing potential defined as pre\-menopausal females with a documented
- •tubal ligation or hysterectomy; or postmenopausal defined as 12 months of
- •spontaneous amenorrheaview protocol for further information.
- •Child\-bearing potential and agrees to use one of the contraception methods listed
- •in Section 8\.1 view protocol for further information.
- •3\. A diagnosis of neuropathic pain due to lumbosacral radiculopathy with the following
- •characteristics1:
Exclusion Criteria
- •1\. Subjects who, in the opinion of the Investigator, are unable to reliably delineate or
- •assess their own pain by anatomical location/distribution (e.g. can the subject
- •reliably tell the difference between their back pain and their lower limb pain and rate
- •their intensity separately ?).
- •2\. Subjects with lumbar canal stenosis in which the pain in the lower limbs occur solely on walking and not at
- •3\. Subjects with causes for their neuropathic pain other than that specified in Inclusion Criterion 3 view protocol,
- •pain associated with a substantial somatic pain component \[e.g.non\-neuropathic /musculoskeletal pain in
- •lower limbs or other parts of the body apart from the back] or more than one cause or potential cause for pain symptoms or any concurrent rheumatic disease such as but not limited to fibromyalgia, rheumatoid arthritis or
- •significant osteoarthritis. Any question regarding the acceptability of aetiology of the neuropathic pain should be
- •discussed with the GSK medical monitor.
Outcomes
Primary Outcomes
Not specified
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