EUCTR2008-008753-33-ES进行中（未招募）不适用
A Randomized, Double-Blind, Placebo- and Active-Controlled Study ofCarisbamate in the Treatment of Neuropathic Pain in Diabetic PeripheralNeuropathy Followed by a Blinded Extension PhaseEstudio Aleatorizado, Doble-Ciego, Controlado con Placebo y Control Activo de Carisbamato en el Tratamiento del Dolor Neuropático en Neuropatía Periférica Diabética, seguido de una Fase de Extensión Ciega
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 440
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
- •? Men or women between 18 and 75 years of age, inclusive
- •? Have diabetes mellitus (Type 1 or Type 2)
- •? Subjects must meet the following criteria at the end of the baseline period to be
- •randomly assigned into the double-blind treatment phase of the study:
- •? Documented daily average DPN pain assessments (ie, evening ratings for
- •pain over the past 24 hours) for at least 5 days in the baseline period
- •? Mean Daily Average DPN Pain score of at least 4 on an 11-point scale during
- •the baseline period
- •? Have symptoms of diabetes-related painful peripheral neuropathy in the distal
- •extremities for at least 6 months prior to study entry. The pain symptoms must be
- •attributable to DPN confirmed by history and findings on neurologic examination.
- •? Experienced lower extremity pain due to diabetic neuropathy on a nearly daily basis
- •for the previous 3 months
- •? Have hemoglobin A1c (HbA1c) levels ?11%
- •? Have a stable diabetic treatment regimen, including oral hypoglycemics, insulin, or
- •diet for 3 months before screening
- •RWJ-333369 (carisbamate): Clinical Protocol CARISNPP2003
- •FINAL ? 21 January 2009 40
- •? Willing to discontinue treatment for chronic pain with AEDs (including gabapentin or
- •pregabalin), opioids or opioid-containing analgesics, or SNRIs or tricyclic
- •antidepressants for any indication. Willing to discontinue other prohibited
- •medications (see Attachment 1).
- •? Women must be:
- •? postmenopausal (for at least 2 years)
- •? surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal
- •ligation, or otherwise be incapable of pregnancy)
- •? abstinent (at the discretion of the investigator/per local regulations)
- •? if sexually active, be practicing a highly effective method of birth control
- •(eg, prescription oral contraceptives provided the subject is receiving a dosage
- •that has been adjusted for concomitant use of any drug known to significantly
- •affect the metabolism of hormonal contraceptives, contraceptive injections,
- •contraceptive patch, intrauterine device, double-barrier method [eg, condoms,
- •diaphragm, or cervical cap, with spermicidal foam, cream, or gel], male partner
- •sterilization) as local regulations permit
- •before entry, and must agree to continue to use the same method of contraception
- •throughout the study.
- •? Women of childbearing potential must have a negative urine pregnancy test at
- •screening; and at the time of random assignment to treatment on Day 1.
- •? Negative urine drug screen and blood alcohol test at screening
- •? Negative for hepatitis B infection, according to the interpretation of hepatitis B
- •serology test results
- •? Negative for anti-hepatitis C virus antibody (anti-HCV)
- •? Able and willing to read and comprehend written instructions, to complete study
- •questionnaires, and to make daily phone calls to the IVRS to report daily DPN pain
- •and sleep assessments
- •? Willing/able to adhere to the prohibitions and restrictions specified in this protocol
- •? Subjects must have signed an informed consent document indicating that they
- •understand the purpose of and procedures required for the study and are willing to
- •participate in the study.
- •? To participate in the optional pharmacogenomic component of this study, subjects
- 另有 5 项未显示
排除标准
- •? History of poor response to 3 or more classes of medications for DPN.
- •Note: Poor response is defined as treatment with medications in the following classes
- •of therapy for greater than 1 month at clinically accepted therapeutic dosages without
- •at least moderate improvement in the judgment of the investigator:
- •? tricyclic antidepressants
- •? opioid analgesics
- •? lidocaine patch
- •? Known allergies, hypersensitivity, or intolerance to carisbamate or its excipients
- •(refer to Section 14.1, Physical Description of Study Drug(s)
- •? History of allergic reaction or other clinically significant or treatment-limiting side
- •effect due to pregabalin
- •? Currently taking Coumadin® (warfarin)
- •? Use of disallowed therapies: see Attachment 1
- •? Prior neurolytic treatment (destruction of nerves by the application of chemicals, heat,
- •or cold), neurosurgery, intrathecal pumps, or spinal cord stimulators for their DPN
- •? Use of herbal topical creams or ointments for pain relief within 48 hours, capsaicin
- •within 6 months, or systemic corticosteroids within 3 months before the baseline
- •? Dermatologic or vascular disease in the limbs affected by the neuralgia that may
- •interfere with assessment, including a diabetic ulcer or any toe or limb amputation
- •? History of a chronic pain condition (eg, joint osteoarthritis or low back pain) that is
- •more severe than their DPN or that requires daily analgesic treatment
- •? Hospitalized within the past 1 month for episodes of hypoglycemia/hyperglycemia
- •? Clinical diagnosis of human immunodeficiency virus (HIV) infection or acquired
- •immunodeficiency syndrome (AIDS) or any immune deficiency
- •? History of progressive or neurologic disorders (eg, multiple sclerosis, amyotrophic
- •lateral sclerosis) that may interfere with completion of the study or interpretation of
- •study results
- •? Medically unstable on the basis of clinical laboratory tests performed at screening. If
- •the results of the serum chemistry panel [including liver enzymes, other specific
- •tests], hematology, or urinalysis are outside the normal reference ranges, the subject
- •may be included only if the investigator judges the abnormalities or deviations from
- •normal to be not clinically significant or to be appropriate and reasonable for the
- •population under study. This determination must be recorded in the subject's source
- •documents and initialed by the investigator. The values must be contained within
- •1.5 times the ULN for ALT and AST, and must be below the ULN for total bilirubin.
- •RWJ-333369 (carisbamate): Clinical Protocol CARISNPP2003
- •FINAL ? 21 January 2009 42
- •? History of liver impairment or renal insufficiency; significant or unstable cardiac,
- •vascular, pulmonary, endocrine, rheumatologic or gastrointestinal conditions
- •including moderate to severe gastroparesis, or an anticipated need for surgery
- •? Glomerular filtration rate (GFR) less than 50 mL/min as estimated by the
- •Modification of Diet in Renal Disease Study Equation:
- •GFR = 175 x (standardized serum creatinine)-1.154 x (age)-0.203 x 0.742 (if subject is
- •female) or x 1.212 (if subject is black)
- •? Known malignancy or history of malignancy within the past 5 years with the
- •exception of basal cell carcinoma that has been treated and is no longer present
- •? History of or suggested clinical diagnosis of schizophrenia, bipolar disorder, dementia
- •due to any cause, or any other psychotic illness
- •? History of suicide attempts or suicidal ideation in the past year
- •? Active, major depression or generalized
研究者
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