A randomised, double blind study to evaluate the safety andefficacy of the p38 kinase inhibitor, GW856553, in subjects withneuropathic pain from peripheral nerve injury

GlaxoSmithKline Research & Development Limited0 sites158 target enrollmentSeptember 17, 2009

Overview

Phase: N/A
Intervention: Not specified
Conditions: Not specified
Sponsor: GlaxoSmithKline Research & Development Limited
Enrollment: 158
Status: Active, Not Recruiting
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 17, 2009

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline Research & Development Limited

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 amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) \> 40 MlU/ml and estradiol \< 40 pg/ml (\<140 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use the contraception methods in Section 8\.1 if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post\-menopausal status prior to study enrollment. For most forms of HRT, at least 2\-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post\-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
•Child\-bearing potential and agrees to use one of the contraception methods listed in Section 8\.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 14 days after the last dose of study medication.
•3\.A diagnosis of peripheral neuropathic pain with the following characteristics:
•Focal neuropathic pain related to nerve injury caused by trauma or surgery not associated with an acute medical condition or injury by avulsion (examples include but are not limited to neuropathic pain secondary to surgical procedures such as thoracotomy, mastectomy, inguinal herniorrhaphy and radical neck dissection, traumatic mononeuropathies and brachial plexus or lumbosacral injuries due to bullet wounds, lacerations, road traffic accidents etc);
•Location of pain consistent with the area innervated by the affected nerve(s), with or without other sensory symptoms in the affected area;
•Duration of pain should be at least 12 weeks since the initial insult.
•4\.Subjects on medications for neuropathic pain (including tricyclic antidepressants, anticonvulsants, opioids, tramadol, bupropion, venlafaxine, mexiletine, muscle relaxants, NMDA antagonists) but excluding NSAIDs, COX\-2 inhibitors, topical lidocaine, topical capsaicin, nerve blocks and steroid injections 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 been on NSAIDs, COX\-2 inhibitors and topical lidocaine may only be included in the study if they have stopped these medications for at least 5 half\-lives prior to the baseline period (Day \-7\). In the case of topical capsaicin, subjects should have stopped this for at least 8 weeks prior to the baseline period.

Exclusion Criteria

•1\.Subjects with other causes for their neuropathic pain \[e.g. trigeminal neuralgia, painful diabetic neuropathy, mononeuritis multiplex, central post\-stroke pain, failed back surgery, phantom limb pain, peripheral neuropathy due to alcoholism, malignancy, HIV, syphilis, drug abuse, vitamin B12 deficiency, hypothyroidism, liver disease, toxic exposure], substantial somatic pain component or more than one cause or potential cause for pain symptoms or nerve entrapment or chronic neck or back pain of more than mild degree or any concurrent rheumatic disease such as but not limited to fibromyalgia or rheumatoid arthritis.
•2\.Subjects with intractable pain of unknown origin or active infection/inflammation in the area of nerve injury.
•3\.Subjects who have had extensive soft tissue injury associated with extensive surgery in the treatment of their nerve injury. Any question regarding the definition of extensive surgery 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.
•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.
•8\.History of excessive regular alcohol consumption within 6 months of the study defined as:
•An average weekly intake of \>21 units or average daily intake \>3 units for males; an average weekly intake \>14 units or average daily intake \>2 units for females. One unit is equivalent to 8 g of alcohol: a half\-pint (\~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
•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.