EUCTR2013-004508-21-DE进行中（未招募）1 期
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF THE SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 849
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
- •- Evidence of a personally signed and dated informed consent document
- •indicating that the subject (or a legally acceptable representative) has
- •been informed of all pertinent aspects of the study.
- •- Male or female =18 years of age.
- •- A diagnosis of osteoarthritis of the hip or knee in the index joint based
- •on American College of Rheumatology criteria with x-ray confirmation (a
- •Kellgren-Lawrence 17 x-ray grade of =2 as diagnosed by the Central
- •- Acetaminophen and oral NSAID therapy do not provide adequate pain
- •relief, or subject is unable to take NSAID; tramadol treatment has not
- •provided adequate pain relief or subject is unable to take tramadol;
- •opioid treatment has not provided adequate pain relief or subject is
- •unwilling to take opioids, or unable to take opioids.
- •- WOMAC Pain subscale Numerical Rating Scale (NRS) =5 in the index
- •joint at Screening.
- •- Subjects must be willing to discontinue all pain medications for
- •osteoarthritis except rescue medication (acetaminophen) and not use
- •prohibited pain medications throughout the duration of the study except
- •as permitted per protocol.
- •- Female subjects of childbearing potential and at risk for pregnancy
- •must agree to use 2 highly effective or acceptable methods of
- •contraception throughout the study and for 112 days (16 weeks) after
- •the last dose of assigned subcutaneous investigational product.
- •- Female subjects who are not of childbearing potential meet at least one
- •of the following criteria:
- •Have undergone a documented hysterectomy and/or bilateral
- •oophorectomy;
- •Have medically confirmed ovarian failure; or
- •Achieved post-menopausal status defined as follows: cessation of
- •regular menses for at least 12 consecutive months with no alternative
- •pathological or physiological cause and have a serum follicle stimulating
- •hormone (FSH) level confirming the post-menopausal state.
- •- Subjects who are willing and able to comply with lifestyle guidelines,
- •scheduled visits, treatment plan, laboratory tests, and other study
- •procedures through the End of Study visit.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 510
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •- Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees directly involved in the conduct of the trial.
- •- Body Mass Index (BMI) of >39 kg/m2.
- •History or radiographic evidence of other diseases that could confound efficacy assessments (e.g., rheumatoid arthritis).
- •History or radiographic evidence of orthopedic conditions that may increase the risk of, or confound assessment of joint safety conditions during the study.
- •- Planned surgical procedure during the duration of the study.
- •- Largely or wholly incapacitated, (eg, subject bedridden or confined to a wheelchair, permitting little or no self-care).
- •- Fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to severe pain that may confound assessments or self-evaluation of the pain associated with osteoarthritis. Subjects with a present (current) history of sciatica are not eligible for participation. Subjects with a past history of sciatica who have been asymptomatic for at least one year and who have no evidence of radiculopathy or sciatic neuropathy on thorough neurologic examination are eligible for participation.
- •- Subjects with a past history of carpal tunnel syndrome (CTS) with signs or symptoms of CTS in the one year prior to Screening.
- •- Subjects considered unfit for surgery, defined as Grade >3 on the American Society of Anesthesiologists (ASA) physical classification system for surgery, or subjects who would not be willing to undergo joint replacement surgery if required.
- •- History of intolerance or hypersensitivity to acetaminophen (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 (refer to product labeling).
- •- Use of prohibited medications without the appropriate washout period (if applicable) prior to Screening or Initial Pain Assessment Period.
- •- Oral or intramuscular corticosteroids within 30 days prior to the Initial Pain Assessment Period.
- •- Intra-articular corticosteroid injection in the index joint within 12 weeks, or to any other joint within 30 days prior to the Initial Pain Assessment Period.
- •- Intra-articular hyaluronic acid injection in the index joint within 30 days (or within 18 weeks for long-acting formulations such as Synvisc) prior to the Initial Pain Assessment Period.
- •- History of cancer within 5 years prior to Screening, except for cutaneous basal cell or squamous cell cancer resolved by excision.
- •See the protocol for additional Exclusion Criteria.
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