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Clinical Trials/EUCTR2009-012836-33-DK
EUCTR2009-012836-33-DKActive, not recruitingNot Applicable

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

GlaxoSmithKline Research & Development Limited0 sites142 target enrollmentStarted: October 5, 2009Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
142
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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:
  • •Pain perceived in one or both lower limbs at sites consistent with the area innervated by the L4, L5 or S1 nerve
  • •roots, with or without other sensory symptoms in the affected areas; (typically, the pain may be perceived in the
  • •buttock, thigh, calf, leg, foot or toes).
  • •History of the pain suggestive that the cause of lumbosacral radiculopathy is due
  • •to injury of the lumbosacral nerve root(s) , view protocol for further information.
  • •Duration of pain should be at least 12 weeks since onset.
  • •Intensity of pain should be stable for the 2 weeks prior to Screening, based on
  • •clinical history.
  • •As part of the neurological examination, the investigator must also conduct the
  • •procedures specified in the Standardised Evaluation of Pain and to calculate the total score. View protocol for
  • •further information.
  • •- Pain/sensory disturbance in dermatomal/myotomal distribution precipitated or
  • •exacerbated by straight leg raising (the straight leg raising test should be
  • •performed as specified in StEP;
  • •- Neurological examination of lower limbs shows impaired muscle power,
  • •sensory function or deep tendon reflexes in the territory of the affected nerve
  • •- The total StEP score is =4 (indicative of lumbosacral radiculopathy as the
  • •cause of the pain);
  • •- Electromyographic (EMG) evidence of denervation in muscles innervated by
  • •the affected nerve roots;
  • •- Quantitative sensory tests (QST) showing evidence of altered sensory
  • •thresholds in dermatomes innerved by the affected nerve roots;
  • •At Screening, if the investigator is satisfied with the diagnosis based on clinical
  • •review, or if results from such investigations related to the current symptoms are
  • •already documented in the medical notes, then it is not essential for the
  • •investigator to conduct computerised tomography (CT)/magnetic resonance imaging (MRI), EMG or QST. View protocol for further information.
  • •However, all subjects who are considered eligible by the Investigator on clinical
  • •grounds but have not had an CT/MRI undertaken to support the diagnosis of LSR
  • •prior to Screening or where a previous CT/MRI scan is not available to the
  • •Investigator, are required to have an CT/MRI undertaken during the
  • •screening/baseline period (Day -28 to Day -1) view protocol for further information.
  • •4. Subjects on medications for neuropathic pain (view protocol) may only be included in the study if they have
  • •been on stable doses of such medications for at least 4 weeks prior to baseline period (Day -7).
  • •5. Subjects who have not received NSAIDs, COX-2 inhibitors and/or topical lidocaine
  • •for at least 5 half-lives or 2 weeks, whichever is longer prior to the baseline period
  • •(Day -7), and for subjects who have not received topical capsaicin for at least 8
  • •weeks prior to the baseline period.
  • •6. Subjects who have not received nerve blocks and/or steroid injections for neuropathic pain for at least 4 weeks

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.
  • •4. A positive pre-study drug/alcohol screen. However, a positive drug screen will not
  • •automatically exclude a subject if there is a medical explanation for the positive
  • •result other than drug abuse e.g. a subject who is taking opioids for their neuropathic pain.
  • •5. A positive test for HIV antibody or positive history of HIV.
  • •6. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody
  • •result within 3 months of screening
  • •7. History of any liver disease within the last 6 months [with the exception of known
  • •Gilbert’s disease].
  • •8. History of excessive regular alcohol consumption within 6 months of the study
  • •defined as outlined in protocol.
  • •9. History or presence of significant cardiovascular, gastro-intestinal, or renal disease
  • •or other condition known to interfere with the absorption, distribution, metabolism,
  • •or excretion of drugs which, in the opinion of the Investigator may interfere with the
  • •study procedures or compromise subject safety.
  • •10. History or presence of any clinically significant abnormality in vital signs / ECG /
  • •laboratory tests, or have any medical or psychiatric condition, which, in the opinion
  • •of the Investigator, may interfere with the study procedures or compromise subject
  • •11. Subject has clinical evidence of recent major depression (by medical history) except those subjects already
  • •controlled by anti-depressants at screening.
  • •12. Subjects who, in the clinical judgement of the investigator, may be malingering or be motivated by secondary
  • •gain from participation in the study will be excluded. View protocol for further information.
  • •13. Changes to medications permitted for the treatment of neuropathic pain (Section 9.1) within 4 weeks of the
  • •baseline period (Day -7), including dose adjustment,
  • •withdrawal of medications or initiation of new medications.
  • •14. Subjects who are unable to maintain the same medications for the treatment of
  • •neuropathic pain at the same stable dose as at baseline during the study.
  • •15. Unable to refrain from excessive use of sedative medications (e.g. benzodiazepines
  • •prescribed as hypnotics) that in the opinion of the Investigator may interfere with
  • •efficacy or safety assessments.
  • •16. Use of other prescription or non-prescription drugs, within 7 days (or 14 days if the drug is a potential enzyme
  • •inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication (Day 1) or during the
  • •study, view protocol for further information.
  • •17. Unable to stop and remain

Investigators

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