EUCTR2014-004996-22-GB进行中（未招募）1 期
A Phase 2a, Randomized, Double-blind, Placebo- and Naproxen-controlled, Parallel-group Study to Assess the Analgesic Efficacy of ASP7962 in Patients with Pain Due to Osteoarthritis of the Knee
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 215
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
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
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
研究者
相似试验
进行中（未招募）
1 期
A trial to investigate the efficacy of ASP7692 in patients with pain due to arthritis in the kneeOsteoarthritis of the kneeMedDRA version: 18.1Level: LLTClassification code 10031165Term: Osteoarthritis kneeSystem Organ Class: 100000004859EUCTR2014-004996-22-ESAstellas Pharma Europe B.V.205
进行中（未招募）
1 期
A trial to investigate the efficacy of ASP7962 in patients with pain due to arthritis in the kneeOsteoarthritis of the kneeMedDRA version: 19.0Level: LLTClassification code 10031165Term: Osteoarthritis kneeSystem Organ Class: 100000004859EUCTR2014-004996-22-CZAstellas Pharma Europe B.V.205
进行中（未招募）
1 期
A trial to investigate the efficacy of ASP7962 in patients with pain due to arthritis in the kneeEUCTR2014-004996-22-HUAstellas Pharma Europe B.V.205
进行中（未招募）
1 期
A trial to investigate the efficacy of ASP7692 in patients with pain due to arthritis in the kneeOsteoarthritis of the kneeMedDRA version: 18.1Level: LLTClassification code 10031165Term: Osteoarthritis kneeSystem Organ Class: 100000004859EUCTR2014-004996-22-BEAstellas Pharma Europe B.V.205
招募中
1 期
Phase 2 Study of Adjuvant V940 and Pembrolizumab in Muscle-invasive Urothelial CarcinomaHigh-risk Muscle-invasive Urothelial Carcinoma Post-radical ResectionMedDRA version: 20.0Level: LLTClassification code: 10064467Term: Urothelial carcinoma Class: 10029104CTIS2023-505658-17-00Merck Sharp & Dohme LLC220