EUCTR2006-002590-44-HU进行中（未招募）不适用
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND COMPARISON OF 4 DOSEREGIMENS OF PLA-695, NAPROXEN, AND PLACEBO ADMINISTERED DAILYFOR 6 WEEKS IN SUBJECTS WITH ACTIVE OSTEOARTHRITIS OF THE KNEE
Wyeth Research Division of Wyeth Pharmaceuticals Inc, Clinical Research and Development0 个研究点目标入组 560 人开始时间: 2006年9月19日最近更新:
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相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 560
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 50 to 75 years of age.
- •a) Women must be of non-childbearing potential; women < or = 55 years must have a negative serum ß-HCG pregnancy test.
- •b)Sexually active men who are not surgically sterile must agree and commit to use of barrier contraception during the study and for at least 12 weeks after the last dose of TA.
- •- Diagnosed with idiopathic OA of the knee for at least 3 months duration in accordance with [1986] American College of Rheumatology (ACR) clinical and radiographic criteria:
- •knee pain, the presence of osteophytes, and any one of the following:
- •age >50 years, crepitus, or morning stiffness <30 minutes.
- •- Radiographic confirmation of OA at the target joint (weight-bearing anteroposterior and lateral views) within 1 year of screening.
- •- Must be ambulatory.
- •- Must be currently treated for OA with a stable daily dose of 1 NSAID, including COX-2 inhibitors, not exceeding the maximum recommended dose in the product label, and taken as prescribed by the physician, starting at least 4 weeks before the screening visit.
- •- Must be willing to discontinue use of all NSAIDs/COX-2 inhibitors during the study
- •- At the baseline visit (2 to 14 days after after discontinuation of NSAID therapy), the scores of the following 3 measures must be at least 3 on a 1 to 5 point categorical scale and demonstrate a 1 category worsening (flare”) in all three measures at the baseline visit as compared with the screening values:
- •a)Walking pain (5-point categorical scale: none, mild pain, moderate pain, severe pain, very severe pain)
- •b)Investigator’s overall evaluation of the subject’s condition (5-point categorical scale: very good, good, fair, poor, very poor)
- •c)Subject’s overall evaluation of his/her condition (5-point categorical scale: very good, good, fair, poor, very poor)
- •- The subject’s overall assessment of walking pain (Question 1 of the Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC] Visual Analog Scale [VAS]) must be =40 mm (0 as no pain” to 100 mm as severe pain”)
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Subjects who have previously not been able to tolerate NSAIDs/COX-2 inhibitors, or have not had a therapeutic response to NSAIDs for OA.
- •- History of known hypersensitivity or allergic reaction to any of the components of PLA-695, sulfonamides, 5-lipoxygenase inhibitors, LT receptor antagonists, acetaminophen/paracetamol, or COX-2 inhibitors/NSAIDs, including aspirin.
- •- History of any surgery at the target knee, including arthroscopic interventional surgical procedure, or anticipated need for any surgery during the study.
- •- Arthroscopy for diagnostic purposes or lavage at the target knee within 1 year of screening, or any invasive procedures anticipated during the study.
- •- Orthopedic surgery of the lower extremities other than the target knee within 6 months of screening, or an anticipated need for such surgery during the study.
- •- History of or suspected current esophageal or gastrointestinal bleeding, ulcers, obstruction, or perforation, or pancreatitis.
- •- Grade 4 severity on the Kellgren
- •-Lawrence Scale on the screening target knee radiograph.
- •- Concomitant inflammatory arthropathy or other diseases or conditions that may affect joints (eg, RA or other auto-immune diseases, metabolic bone disease, psoriatic arthritis, gout, pseudogout, infection of the target knee, chondrocalcinosis in the target knee, Paget’s disease, neuropathic conditions, hemochromatosis).
- •- History of acute trauma leading to secondary OA of the target knee.
- •- Cancer, or a history of cancer (other than successfully resected cutaneous basal and squamous cell carcinoma) within 5 years before the screening visit.
- •- Any significant cardiovascular, hematologic, blood dyscrasia, endocrine, respiratory, neurologic, psychiatric, metabolic, immunologic, infectious, hepatic, or renal condition that the investigator considers detrimental to the subject’s participating in the study or that may prevent the successful completion of the study, including the following:
- •a)Cardiovascular disease:
- •i)History of myocardial infarction.
- •ii)History of angina pectoris.
- •iii)Cardiac arrhythmia or clinically significant electrocardiogram (ECG) abnormality, such as ischemia.
- •iv)History of stroke or transient ischemic attack. v)Congestive heart failure (CHF) New York Heart Association classification for CHF: Class III or IV.
- •vi)Uncontrolled hypertension (systolic blood pressure [SBP] =140 mmHg or diastolic blood pressure [DBP] =90 mmHg).b)Poorly controlled diabetes.
- •c)Known or suspected untreated infections with Helicobacter pylori infection.
- •d)History of human immunodeficiency virus (HIV) infection or known risk of HIV disease.
- •- Any clinically significant laboratory abnormality, including those listed below:
- •a)Liver function abnormality (total bilirubin >1.5 x the upper limit of normal [ULN], aspartate aminotransferase [AST/SGOT] > 1.2 x ULN, alanine aminotransferase [ALT/SGPT] > 1.2 x ULN).
- •b)Anemia (hemoglobin or hematocrit below the lower limit of normal).
- •c)Thrombocytopenia or thrombocytosis (platelets <125,000/mm3 or =1,000,000/mm3 [SI units:<125 x 109/L or = 1,000 x 109/L])
- •d)Renal function abnormality, including serum creatinine level greater than the upper limit of normal.
- •e)Positive qualitative serologic findings for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies.
- •f)Fasting serum triglyceride levels > 500 mg/dL (SI units:>5.65 mmol/L).
- •g)Serum amylase or serum lipase = 1.25 x ULN.Screening laboratory tests with abnormal results may be repeated once t
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