A Phase 2a, Randomized, Double-blind, Placebo- and Naproxen-controlled, Parallel-group Study to Assess the Analgesic Efficacy of ASP7692 in Patients with Pain Due to Osteoarthritis of the Knee

Astellas Pharma Europe B.V.0 个研究点目标入组 205 人开始时间: 2015年12月16日最近更新: 2018年3月26日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Astellas Pharma Europe B.V.
入组人数: 205

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

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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

•1. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations.
•2. Patient is a male or female patient and aged 18 to 80 years, at screening.
•3. Patient has a primary diagnosis of OA of the index knee with symptoms for at least 6 months prior to screening and patient meets American College of Rheumatology clinical classification criteria for OA of the knee, defined by the following.
•Knee pain and at least 3 of the following 6 (a-f):
•a) Age > 50 years
•b) Morning stiffness < 30 minutes
•c) Crepitus on active motion
•d) Bony tenderness
•e) Bony enlargement
•f) No palpable warmth of synovium
•4. Patient has a radiographic image of the index knee (according to the minimum quality criteria for radiographic image as set by the central radiology reader) showing evidence of OA with a Kellgren-Lawrence grade = 2 at screening (based on central reading).
•5. Patient has moderate to severe index knee pain (pain due to OA of the knee at least 5 days per week for the last 3 months prior to screening, as determined by patient’s medical history).
•6. Patient is ambulatory and the index knee must not contain any orthopedic and/or prosthetic device.
•7. WOMAC pain subscale score (with a 48-hour recall period) in the index knee = 4 at baseline (visit 2 predose, mean of all questions on pain subscale).
•8. This criterion has been removed.
•9. WOMAC physical function subscale score = 4 at baseline (visit 2 predose, mean of all questions on the physical function subscale with a 48-hour recall period).
•10. Patient is willing to discontinue all current pain medications during the baseline and treatment periods (until day 57) (except for allowed rescue medications). Low dose aspirin for cardioprophylaxis is allowed.
•11. Patient is compliant with daily pain recording.
•12. Male patient and their female spouse/partners who are of
•childbearing potential must be using a barrier method* and 1 form of
•highly effective birth control** starting at screening and continuing
•throughout the study period and for 90 days after the final study drug
•administration.
•13. Male patient must not donate sperm starting at screening and throughout the study period and for 90 days after the final study drug administration.
•14. Female patient must either:
•? Be of non childbearing potential:
•¦ post-menopausal (defined as at least 1 year without any menses) prior to screening, or
•¦ documented surgically sterile
•? Or, if of childbearing potential:
•¦ agree not to try to become pregnant during the study and for 28 days after the final study drug administration,
•¦ and have a negative pregnancy test at screening and at baseline (visit 2 predose),
•¦and, if heterosexually active, agree to consistently use a barrier
•method* and 1 form of highly effective birth control** starting at
•screening and continuing throughout the study period and for 28 days
•after the final study drug administration.
•15. Female patient must agree not to breastfeed starting at screening and continuing throughout the study period and for 28 days after the final study drug administration.
•16. Female patient must not donate ova starting at screening and continuing throughout the study period and for 28 days after the final study drug administration.
•17. Patient agrees not to participate in another investigational study from screening through the follow-up period (until day 57).
•* Barrier methods of

排除标准

•3.Current or prior clinically significant neurologic disease, including but
•not limited to peripheral neuropathy, stroke, cognitive impairment and
•4.Any clinically significant uncontrolled musculoskeletal disorder (with
•the exception of OA), cardiovascular, gastrointestinal, endocrinologic
•(diabetes mellitus is allowed if controlled [glycated hemoglobin (HbA1c)
•= 8.0%] and no peripheral neuropathy), hematologic, hepatic,
•immunologic, metabolic, urologic, pulmonary, dermatologic, renal
•and/or other major disease.
•5.Active malignancy or a history of malignancy (except for treated
•nonmelanoma skin cancer) within the past 5 years.
•6.History of inflammatory arthritis (including rheumatoid arthritis), or a
•history of RPOA (including osteonecrosis or avascular necrosis of bone
•and/or joints), or has other diagnoses that may increase the risk of
•RPOA, or severe knee malalignment or any other joint-related condition
•that makes the patient unsuitable for study participation.
•7.Findings suggestive of RPOA or increased risk for RPOA on screening
•radiographs of either index or non-index joints.
•8.History of shoulder surgery, clinically significant trauma or current
•symptoms, including pain or impaired range of motion at shoulder joint.
•9.Patient has a coagulopathy, is receiving anticoagulants or has been
•diagnosed with thrombocytopenia or a functional platelet disorder.
•10.History of paracetamol intolerance, or existence of medical condition
•or use of concomitant medication for which paracetamol is
•controindicated.
•11.Any contraindication to naproxen.
•12.Any contraindication to tramadol.
•15.a.Lifetime history of ischemic or hemorrhagic stroke, cardiac arrest,
•torsade de pointes, clinically significant structural heart disease or a
•personal or family history of long QT syndrome. b.Within 12 months
•prior to visit 2: acute coronary syndrome (e.g.,myocardial infarction,
•unstable angina [ischemic heart disease is allowed, if in the
•investigator's opinion, it is clinically stable]); transient ischemic attack;
•coronary or peripheral revascularization procedure; clinically significant
•cardiac arrhythmias (including atrial fibrillation or flutter), heart block
•(first degree heart block is allowed provided PR interval is not greater
•than 240 msec) or other clinically significant cardiovascular disorder.
•c.Current heart failure (NYHA class III and IV).
•16.Resting pulse rate < 50 or > 100 beats per minute (bpm); systolic
•blood pressure (SBP) > 160 mm Hg; diastolic blood pressure (DBP) > 90
•mm Hg at screening or baseline.
•17.History of unexplained syncopal events or has symptomatic
•orthostatic hypotension at screening or baseline, defined as postural
•related symptoms and at least one of the following: standing SBP = 20
•mm Hg lower than supine SBP, standing DBP = 10 mm Hg lower than
•supine DBP.
•19.Any liver tests (aspartate aminotransferase [AST], alanine
•aminotransferase [ALT], total bilirubin [TBL]) > 1.5 times the upper limit
•of normal [ULN] at screening.
•20.Estimated glomerular filtration rate of = 60 mL/min/1.73m2 (MDRD
•calculation) at screening.
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研究者

发起方

Astellas Pharma Europe B.V.

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