EUCTR2009-009856-19-PL进行中（未招募）不适用
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 as Adjunctive Therapy in Subjects With Moderate to Severe Knee or Hip Pain From Osteoarthritis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 420
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
- •Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- •·Man or woman 40 to 80 years of age, inclusive
- •·Clinical diagnosis of osteoarthritis of the hip or the knee based on criteria defined by the American College of Rheumatology; radiographic evidence of osteoarthritis (Kelgren Lawrence class =2) of the study joint must be documented prior to randomization
- •·Have an average pain intensity score of =5 averaged over the last 3 days of pain scores before randomization (Day 1) using an 11-point NRS, where the minimum single assessment score is =2. Subjects must have a minimum of 5 out of 6 possible assessments (twice daily assessments for the last 3 days of pain scores).
- •·Must be receiving at least one of the following analgesic regimens:
- •–Stable dose of NSAIDs for a minimum of 5 days each week for the 4 weeks before screening
- •–Stable dose of immediate-release opioids for a minimum of 5 days each week for the 4 weeks before screening, but not exceeding 200 mg oral morphine equivalents per day
- •–Stable dose of long acting opioids for the 4 weeks before screening; but not exceeding 200 mg oral morphine equivalents per day; subjects on long-acting opioids who use immediate release opioids for breakthrough pain must not exceed, on average, more than 2 doses of immediate release opioids per day during any 7-day period
- •·Have a MMSE score of =26 at screening
- •·Subjects who are sexually active must consent to utilize and document a medically acceptable and highly effective (<1% per year failure rate) method of contraception throughout the entire study from screening through 6 months after the last dose of study drug
- •–Medically acceptable, highly effective methods of contraception that may be used by the subject and/or partner include hormonal oral, transdermal, progestin implant, or injectable contraception, or intrauterine device (IUD), tubectomy or vasectomy
- •–For all women of childbearing potential, contraception must be consistently used for at least 3 months before the first dose of study drug through 6 months after the last dose of study drug. The screening phase may be extended up to 3 months to meet this requirement, but baseline safety evaluations must be performed within 3 weeks before the first dose of study drug.
- •–Subject or partner may also be postmenopausal (states having not experienced a menstrual period for a minimum of 12 months) or surgically sterile
- •–Further, subjects must agree to not donate sperm or eggs or attempt conception (pregnancy) from screening through 6 months after the last dose of study drug
- •·Women of childbearing potential must have a negative serum beta human chorionic gonadotropin (b hCG) pregnancy test at screening (serum) and a negative urine b hCG pregnancy test at randomization (Day 1)
- •·Medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead ECG performed at screening
- •·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 must have signed the informed consent form for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study (where local regulatio
排除标准
- •Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- •History within the past year of any of the following:
- •–Seizure disorder
- •–Intrathecal therapy and ventricular shunts
- •–Mild or moderate traumatic brain injury
- •–Transient ischemic attack
- •–Meningitis
- •History of brain injury within the past 15 years consisting of =1 of the following, or with residual sequalae suggesting transient changes in consciousness:
- •–Brain contusion
- •–Intracranial hematoma
- •–Either unconsciousness or posttraumatic amnesia lasting more than 24 hours
- •History of epilepsy or multiple sclerosis
- •Current diagnosis of fibromyalgia, complex regional pain syndrome (including reflex sympathetic dystrophy or causalgia), study joint pain caused by secondary infection, or pain caused by confirmed or suspected neoplasm
- •Any new or unresolved neurologic deficits, including progressive deficits, within 6 months before screening. Transient neurologic deficits that are resolved within this period can be allowed if approved by the investigator.
- •Active peripheral neuropathy, paresthesia, or dysesthesia, or any other previously diagnosed neurologic condition causing the above noted symptoms
- •History of ocular herpes simplex, HSV pneumonia, or HSV encephalitis
- •History of primary HSV infection and/or recurrent reactivation within the past 2 years or prophylactic therapy for HSV within the past 2 years.
- •Currently receiving chronic systemic immunosuppressive therapy
- •History of joint replacement surgery in the study joint or planned surgery for the study joint during the 12-week double-blind efficacy phase
- •History of a major surgical procedure (ie, involving general or regional anesthesia), significant trauma, or a nonhealing wound or ulcer within 3 months before the screening visit
- •Steroid injections in the study joint within 8 weeks before the screening visit
- •Hyaluronic acid injection into the study joint within 3 months before the screening visit
- •Diagnosis of diabetes mellitus or laboratory results consistent with diabetes mellitus (ie, fasting glucose =126 mg/dL or =7 mmol/L)
- •Alanine aminotransaminase (ALT) or aspartate aminotransaminase (AST) =2.5 times the upper limit of normal (ULN)
- •Serum creatinine of =1.8 mg/dL
- •History of drug or alcohol abuse within the past 5 years
- •History or suspected human immunodeficiency virus infection (Note: HIV testing is not required for this study)
- •Severe depression as defined by a score of =29 on the BDI II at screening
- •Any other pain condition that, in the investigator’s opinion, would interfere with the assessment of osteoarthritis
- •History of malignancy within the past 2 years, with the exception of basal cell carcinoma that has been successfully treated
- •Uncontrolled cardiovascular disease or hypertension (repeated systolic blood pressure (SBP) >160 mmHg or diastolic blood pressure (DBP) >100 mmHg)
- •Prior treatment with any other investigational NGF inhibitor therapy
- •Known allergies, hypersensitivity, or intolerance to JNJ-42160443 or its excipients, including mammalian cell-derived (ie, Chinese hamster ovary) products
- •Received an investigational drug or used an investigational medical device within 30 days before the screening visit (or 5 half-lives of the investigational drug, whichever is longer) or are currently enrolled in an investigational study
- •Pregnant or breast-feeding
- •Pending litigation due to chronic pain or disability
研究者
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