EUCTR2008-007478-39-ES进行中（未招募）不适用
ESTUDIO MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE JNJ-42160443 EN PACIENTES CON NEURALGIA POSTHERPÉTICA Y NEURALGIA POSTRAUMÁTICA, SEGUIDO DE UN PERIODO DE EXTENSIÓN DOBLE CIEGO DE SEGURIDAD Y UNA EXTENSIÓN ABIERTA DE SEGURIDAD.
Janssen Cilag International, N.V.0 个研究点目标入组 200 人开始时间: 2009年8月11日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
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
- 性别
- All
入选标准
- •? Man or woman between 18 and 80 years of age, inclusive
- •? Subjects who have chronic neuropathic pain (pain persistent for greater than 6 months) that is moderate to
- •severe in the opinion of the investigators) and are currently taking pain medication but are not adequately
- •controlled by standard of care (which may include antidepressants, antiepileptics, topical lidocaine, or opiods) or
- •are not currently taking pain medications because they are intolerable to, or not willing to use, standard of care.
- •? Subjects currently taking medications for the treatment of neuropathic pain at Screening have 3 options:
- •? They may continue taking their current pain medication: Subjects are required to be on a stable dose for at least
- •4 weeks prior to the first dose of study drug and must remain on this dose for the duration of the double blind
- •efficacy phase. The number and doses of medications for the treatment of neuropathic pain are limited to the
- •guidelines provided below (refer to Maximal Neuropathic Pain Medication Allowed). If the number and/or doses
- •of such medications must be reduced to fall within the acceptable limits for this study, then the number and/or
- •doses must be reduced (see next bullet).
- •? They may reduce the number and/or dose of their current pain medications: If the number and/or dose exceed
- •the limits of allowed neuropathic pain medications (refer to Maximal Neuropathic Pain Medication Allowed),
- •then the number and/or dose must be reduced to fall within acceptable limits. This must be achieved at least 3
- •days or 5-half lives of the pain medication taken (whichever is longer) prior to the beginning of the Interactive
- •Voice Response System (IVRS) baseline period. Medications with the potential to cause withdrawal symptoms
- •should be tapered using a taper schedule that is determined by the investigator. Subjects must remain on this
- •lowered number/dose of pain medication dose for the duration of the double blind efficacy phase.
- •? They may discontinue their current pain medication: If they choose to discontinue their neuropathic pain
- •medications, then a washout interval of 3 days or 5 half lives of the pain medication taken, whichever is longer,
- •prior to beginning the IVRS baseline period is required. Medications with the potential to cause withdrawal
- •symptoms should be tapered using a taper schedule that is determined by the investigator.
- •Maximal pain medication allowed: Use of two or less of the following medications, each one from a different
- •class, is permitted:
- •? Anticonvulsants: gabapentin (? 1800 mg/day) or pregabalin (? 300 mg/day)
- •? Opioid analgesics (? 60 mg/day oxycodone equivalent) or tramadol (? 200 mg/day)
- •? Antidepressants: tricyclic antidepressants (? 75 mg/day amitriptyline equivalent), duloxetine (? 60 mg/day), or
- •venlafaxine (? 150 mg/day)
- •? Subjects must have a mean average pain intensity score of at least 5, but less than 10, over 7 consecutive days
- •on an 11-point numerical rating scale during the IVRS baseline period. Subjects are not permitted to have a pain
- •score of less than 3 on 2 or more days within the 7 consecutive days. During the 7 consecutive days, at least 5
- •days of scores are required.
- •? Subjects with PHN:
- •o Diagnosis of PHN includes a clear history of herpetic (varicella-zoster) rash and persistent pain in a dermatomal
- •distribution area
- •o Pain must be present for greater than 6 months after the onset of the dermatomal rash
- •? Subjects with post-traumatic neuralgia are required to have all of the fol
排除标准
- •? History of a separate pain condition (e.g., joint osteoarthritis) that is more severe than their pain due to their
- •diagnosis of PHN or post-traumatic neuralgia, or, if in the opinion of the Investigator, the chronic pain condition
- •could confound the subject?s assessment of neuropathic pain under this study
- •? Subjects with post-traumatic neuralgia that are characteristic of complex regional pain syndrome Type I,
- •including: pain out of proportion to the severity of the injury, pain outside the distribution of nerve injury,
- •changes in the skin color and/or temperature in the affected limb or body part, edema or excessive sweating of
- •the affected limb or body part. Note, subjects with Type II CRPS are allowed in the study.
- •? Subjects with lumbar-sacral radiculopathy, failed low-back surgery, or spinal cord injury.
- •? Subject whose nerve injury or pain is expected to recover in the next 4 months
- •? Subjects with evidence of another neuropathic pain not under study, such as pain resulting from diabetic painful
- •neuropathy, sensory neuropathies or pain caused by radiation, chemotherapy, alcohol, HIV infection
- •? Other peripheral neuropathy, paresthesia, or dysesthesia, or any other previously diagnosed neurologic condition
- •causing the above noted symptoms that is not related with the PHN or posttraumatic neuralgia under the study
- •? Participation in an analgesia trial within 90 days of the first planned dose of study drug.
- •? Major surgeries (general or regional anesthesia), trauma, and nonhealing wounds/ulcers within 3 months prior to
- •? History (within 1 year) of seizure, intrathecal therapy and ventricular shunts, radiotherapy to the cerebral area,
- •mild or moderate traumatic brain injury, transient ischemic attack, or stroke, or meningitis
- •? History of severe traumatic brain injury within the past 15 years (consisting of 1 or more of the following: brain
- •contusion, intracranial hematoma, either unconsciousness or post-traumatic amnesia lasting more than 24 hours)
- •or with residual sequelae suggesting ongoing transient changes in consciousness
- •? History of epilepsy or multiple sclerosis
- •? In the investigator?s opinion, in consultation with the medical neurologist, any other conditions that could
- •compromise the blood-brain barrier
- •? History of a malignancy (within the past 5 years) or current malignancy with the exception of basal cell
- •carcinoma that has been treated and is no longer present
- •? Received an investigational drug (including vaccines) or used an investigational medical device within 30 days
- •before the planned start of treatment (or 5 half-lives of the investigational drug, whichever is longer) or are
- •currently enrolled in an investigational study.
- •? Women who are pregnant or breast-feeding
- •? Significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic,
- •psychiatric (e.g., schizophrenia, bipolar disorder, dementia), immunological (e.g., immune deficiency), or
- •metabolic disturbances
- •? Type I or Type II diabetes, based on medical history or laboratory results consistent with diabetes mellitus (i.e.
- •fasting plasma glucose ?126 mg/dl or ?7 mmol/L)
- •? Alanine aminotransaminase (ALT) or aspartate aminotransaminase (AST) ? 2.5 times the upper limit of normal
- •? Serum creatinine of ? 1.8 mg/dL
- •? Active, major depression or generalized anxiety disorder, recent episode of either disorder within the past 3
- •months, and subjects with a BDI II score ? 29 (Attachment 1 of protocol).
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