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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00390845 |
This will be a double-blind, placebo controlled cross-over study. After enrolment and initial assessments, subjects will receive oral SB681323 or matching placebo for 14 days. SB681323 will be administered twice daily at a total daily dose of 7.5mg. Sufficient numbers of patients will be recruited to obtain 40 evaluable patients
Condition | Intervention | Phase |
---|---|---|
Neuropathic Pain Nerve Trauma |
Drug: SB681323 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind Placebo-Controlled Study of the Efficacy and Safety of the P38 Map Kinase Inhibitor SB681323 in Patients With Neuropathic Pain Following Nerve Trauma |
Estimated Enrollment: | 40 |
Study Start Date: | August 2006 |
Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Male or female subjects 18-80 years of age
To be eligible, females patients must have a negative pregnancy test (i.e. serum beta hCG test) and be of:
OR b.childbearing potential and agree to commit to one of the protocol-approved methods of contraception, when used consistently and in accordance with both the product label and the instructions of a physician, as indicated below: i.oral contraceptive (combined or progestin only), and the same oral contraceptive regimen has been used for at least two months prior to study drug administration, and the same method continues throughout the study and through the follow-up phase of the study.
ii.progesterone implanted rods (Norplant ) inserted for at least two months prior to the study drug administration (but not beyond the third successive year following insertion) , and is continued throughout the study and through the follow-up phase of the study.
iii.an IUD, inserted by a qualified clinician, with published data showing that the highest expected failure rate is less than 1% per year (not all IUDs meet this criterion) Acceptable IUDs: TCu-380A (Paragard), TCU-380 Slimline (Gyne T Slimline), TCu-220C, MULTILOAD-250 (MLCu-250) and 375, NOVA T and CUNOVAT (Novagard), Levonorgesterol (LNG-20) Intra-uterine System (Mirena/Levonova), and FlexiGard 330/CuFix PP330 (Gynefix). The device must be inserted at least 2 weeks prior to the Screen visit, and remain throughout the study and through the follow-up phase of the study.
iv.injectable medroxyprogesterone acetate (e.g., Depo-Provera) and is on a stable dose for 2 months prior to Screen, throughout the study and through the follow-up phase of the study. v.complete abstinence from intercourse from at least two weeks prior to Screen, throughout the treatment phase, and the follow-up phase.
vi.double barrier method if comprised of a spermicide with either a condom or diaphragm from at least two weeks prior to Screen, throughout the treatment phase, and the follow-up phase.
A diagnosis of peripheral neuropathic pain:
warm sensation > 9.6 0C and cool sensation > 5.6 0C - in L4, L5 or S1 dermatomes) [Quraishi, 2004].
Exclusion criteria:
Any clinically significant medical history or abnormality found on physical examination, laboratory assessment or ECG at screening which, in the opinion of the investigator, could interfere with the interpretation of efficacy or safety data or which otherwise would contraindicate participation in a clinical study, in particular:
trigeminal neuralgia, painful diabetic neuropathy, central post-stroke pain, phantom limb pain, peripheral neuropathy due to alcoholism, malignancy, HIV, syphilis, drug abuse, vitamin deficiency, hypothyroidism, liver disease, toxic exposure, or chronic neck pain);
GI disorders that may interfere with safety assessments, e.g. diarrhoea.
Australia, New South Wales | |
GSK Investigational Site | |
Broadmeadow, New South Wales, Australia, 2292 | |
GSK Investigational Site | |
Randwick, New South Wales, Australia, 2031 | |
Russian Federation | |
GSK Investigational Site | |
Moscow, Russian Federation, 117292 | |
United Kingdom | |
GSK Investigational Site | |
London, United Kingdom, W12 0NN | |
GSK Investigational Site | |
Liverpool, United Kingdom, L9 7LJ | |
United Kingdom, West Midlands | |
GSK Investigational Site | |
Solihull, West Midlands, United Kingdom, B91 2JL |
Study Director: | GSK Clinical Trials, MD, PhD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | MKN106762 |
Study First Received: | October 18, 2006 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00390845 History of Changes |
Health Authority: | United Kingdom: Research Ethics Committee |
P38 SB681323 neuropathic pain |
nerve trauma patients MAP kinase |
Wounds and Injuries Mitogens Pain |