EUCTR2009-013329-41-DK进行中（未招募）不适用
A Phase 3 Randomized, Double-Blind, Placebo- and Oxycodone-Controlled, Multicenter Study of the Efficacy and Safety of Tanezumab in Patients with Osteoarthritis of the Knee or Hip
适应症
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
- 800
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
- •Patient eligibility should be reviewed and documented by an appropriately qualified
- •member of the investigator’s study team before patients are included in the study.
- •Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study.
- •1. Patients must consent in writing to participate in the study by signing and dating an Informed Consent Document indicating that the patient has been informed of all
- •pertinent aspects of the study prior to completing any of the Screening procedures;
- •2. Male or female of any race, 18-75 years of age, inclusive;
- •3. Patients must have a diagnosis of OA of the knee or hip based on American College of Rheumatology criteria with X-ray confirmation (a Kellgren-Lawrence24 x-ray grade of =2) X-rays taken within the last 12 months may be used for confirmation;
- •4. Patients must regularly use analgesic medication, defined as > 4 days per week for the last month prior to Screening. Analgesic medication may consist of NSAIDs,
- •selective COX-2 inhibitors, opioids or combinations thereof. Acetaminophen cannot
- •be the sole analgesic used;
- •5. At least one of the following three criteria must be met.
- •Non-opioid pain medications (eg, NSAIDs) or opioid medications at prescribed doses less than or equal to a morphine equivalent of 90 mg/day (oxycodone 60 mg/day) have not provided adequate pain relief or
- •Patient are unable to take non-opioid pain medications (eg, NSAIDs) or
- •Patients are candidates for or seeking invasive interventions such as intra-articular
- •injections, knee or hip arthroplasty, or knee or hip replacement surgery;
- •6. WOMAC Pain subscale NRS =4 in the index knee or index hip at Screening with or
- •without analgesic medication;
- •7. WOMAC Pain subscale NRS =5 in the index knee or index hip at Baseline;
- •8. An increase of =1 point in WOMAC Pain subscale NRS in the index knee or index
- •hip from Screening to Baseline;
- •9. WOMAC Physical Function subscale NRS =4 in the index knee or index hip at Baseline;
- •10. Patient Global Assessment of Osteoarthritis must be fair,” poor,” or very poor” at Baseline;
- •11. Patients must be willing to discontinue all pain medications for OA except rescue
- •medication and not use prohibited pain medications throughout the duration of the
- •study except as permitted per Protocol;
- •12. Female patients must meet one of the following criteria:
- •a. Female patients of non-childbearing potential:
- •Must be post-menopausal, defined as women who are =45 years old with
- •amenorrhea for 24 consecutive months (regardless of FSH levels), or women who are amenorrheic for at least 1 year AND have a serum Follicle-Stimulating Hormone (FSH) level greater than 30 IU/L at Screening; or
- •Must be surgically sterile, defined as having had a hysterectomy and/or
- •bilateral oophorectomy.
- •b. Female patients of child-bearing potential:
- •Must not be pregnant or lactating; and
- •Must be abstinent or use adequate contraception (2 forms of birth control,
- •one of which must be a barrier method); and
- •Must have a negative serum pregnancy test at Screening (within 30 days prior to Baseline) and a negative urine pregnancy test at Baseline prior to initial dosing.
- •Male patients must agree that they and their female spouses / partners will use
- •adequate contraception (2 forms of birth control, one of which must be barrier
- •method) or be of non-childbearing potential.
- •Females of child-bearing potential and males must be willing to use approved methods of contraception from commencement of screen
排除标准
- •1. Pregnant women, lactating mothers, women suspected of being pregnant, and women who wish to be pregnant
- •2. Body mass index (BMI) of >39 kg/m2
- •3. History of inflammatory joint diseases, crystalline disease (gout or pseudogout), endocrinopathies, metabolic joint diseases, lupus erythematosus, rheumatoid arthritis, joint infections, neuropathic disorders, avascular necrosis, Paget’s disease, or tumors
- •4. Significant trauma or surgery to the index joint within the previous year;
- •5. Planned surgical procedure
- •6. Largely or wholly incapacitated
- •7. Fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy
- •8. Other pain that may confound assessments or self-evaluation of pain
- •9. History of cancer within the last 5yrs
- •10. Signs and symptoms of clinically significant cardiac disease including but not limited to
- •Ischemic cardiac disease
- •Surgery or stent placement for coronary artery disease in the 6 months prior to
- •New York Heart Association (NYHA) Class III or IV congestive heart failure or known left ventricular dysfunction with ejection fraction =35%, cardiomyopathy, myocarditis in the 6 months prior to Screening
- •Resting tachycardia (heart rate =120) or resting bradycardia (heart rate =45) on ECG at Screening or Baseline
- •QTc interval >500 msec in the absence of bundle branch block or paced rhythm
- •Any CV illness that would render a patient unsuitable to participate
- •11. Diagnosis of a transient ischemic attack in the 6 months or diagnosis of stroke with residual deficits (eg, aphasia, substantial motor or sensory deficits)
- •12. History, diagnosis, or signs and symptoms of clinically significant neurological
- •disease, including but not limited to
- •Alzheimer’s disease or other types of dementia
- •Clinically significant head trauma within the past year
- •Peripheral neuropathy
- •Multiple sclerosis
- •Epilepsy or seizure
- •13. History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder, including but not limited to
- •Psychotic disorders
- •Somatoform disorders
- •Bipolar disorders
- •Any other psychiatric illness that would render a patient unsuitable
- •14. Hospital admission for depression or suicide attempt within 5 years of Screening or active, severe major depression at Screening
- •15. History of known alcohol, analgesic or non-narcotic drug abuse within 2 years
- •16. Any history of known opioid or narcotic abuse
- •17. Previous exposure to exogenous NGF or to an anti-NGF antibody
- •18. Exposure to opioids at doses exceeding a morphine equivalent of 90 mg/day
- •(oxycodone 60 mg/day) within 30 days prior to Screening is exclusionary
- •19. Use of any analgesic from Screening to the start of the Initial Pain Assessment Period (the 3 days prior to Randomization/Baseline) without a sufficient washout
- •20. History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein
- •21. History of intolerance or hypersensitivity to paracetamol or any of its excipients or existence of a medical condition or use of concomitant medication for which the use of acetaminophen is contraindicated
- •22. History of intolerance or hypersensitivity to oxycodone or any of its excipients
- •23. Patients taking >325 mg/day of aspirin (or any salicylate containing medications).
- •24. Existence of a medical condition for which the use of oxycodone is contraindicated
- •25. Resting, sitting blood pressure (BP) =160 mm Hg in systolic pressure or =100 mm Hg or diastolic blood
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