EUCTR2006-001072-21-GB进行中（未招募）1 期
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
GlaxoSmithKline Research and Development Ltd0 个研究点目标入组 0 人开始时间: 2007年8月1日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Male or female subjects 18-80 years of age
- •2. To be eligible, females patients must be of:
- •a. non-childbearing potential (i.e. physiologically incapable of becoming pregnant).
- •This includes any female who is post-menopausal. For the purposes of this study,
- •post menopausal is defined as being amenorrhoeic for greater than 2 years with an
- •appropriate clinical profile, e.g. age appropriate, history of vasomotor symptoms.
- •Postmenopausal status will be confirmed by serum FSH and oestradiol
- •concentrations at screening. Surgical sterility will be defined as females who have
- •had a hysterectomy and/or bilateral oophorectomy or tubal ligation.
- •b. childbearing potential and have a negative pregnancy test 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 (e.g. 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), 375 and 375 SL, 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.
- •3. A diagnosis of peripheral neuropathic pain:
- •focal neuropathic pain related to nerve injury caused by trauma or surgery not
- •associated with ongoing infection (examples include post-thoracotomy
- •syndrome, post-mastectomy syndrome, post-inguinal herniorrhaphy syndrome,
- •post-radical neck dissection syndrome, traumatic mononeuropathies- bullet
- •wounds, lacerations, road traffic
排除标准
- •1. 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:
- •subjects with non-neuropathic pain component involvement, mononeuropathy
- •multiplex, or more than one cause or potential cause for pain symptoms (e.g.
- •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);
- •subjects with intractable pain of unknown origin or active infection in the area of
- •nerve injury/compression;
- •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;
- •history of Gilbert's syndrome or elevated bilirubin levels (total, direct or indirect) in
- •a previous clinical study or at screening;
- •history of increased liver function tests (ALT, AST) above upper limit of normal in
- •the past 6 months;
- •positive Hepatitis B surface antigen, positive Hepatitis C antibody or Hepatitis C
- •nucleic acid result;
- •GI disorders that may interfere with safety assessments, e.g. diarrhoea.
- •2. Recent start or change in dosing regimen (=1 month prior to randomisation) of any medication which, in the opinion of the Investigator, may interfere with pain
- •assessments or introduce a risk of drug-drug interactions (see Section 9.2, Prohibited
- •Medications for details). Subjects may continue to take medications for the treatment
- •of their neuropathic pain as long as the regimen is stable and does not contain
- •prohibited medications.
- •3. Unable to refrain from excessive use medications (e.g. sedatives) that in the opinion of Investigator may interfere with efficacy or safety assessments (benzodiazepines prescribed as hypnotic sleep agents allowed). Subject is unable to discontinue topical analgesics prior to randomization and for the duration of the study (see Section 9.2, Prohibited Medications for details).
- •4. Subject is unable to refrain from nerve blocks during the study.
- •5. Positive alcohol test or urine drug screen at screening. 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.
- •6. History of regular alcohol consumption exceeding an average weekly intake of > 21 units (or an average daily intake of greater than 3 units) for males, or an average
- •weekly intake of > 14 units (or an average daily intake of greater than 2 units) for
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