EUCTR2005-000149-12-BE进行中（未招募）不适用
A Phase III, 12-week, Multicentre, Double-blind, Double-dummy, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group study to investigate the Efficacy and Safety of GW406381 1mg, 5mg, 10mg, 25mg and 50mg administered orally once daily, in adults with Osteoarthritis of the knee
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
- 1,120
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
- •1.Subject is male or female outpatient, = 40 years of age.
- •A female is eligible to participate in this study if she is of:
- •aNon-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre-menarchal or post-menopausal); or,
- •bChild-bearing potential has a negative pregnancy test and is not lactating at the Screening and Baseline/Randomisation Visits and agrees to satisfy one of the requirements listed in Appendix 2: Acceptable Methods of Contraception.
- •2.Subject is able and willing to give written informed consent
- •3.Subject is able to read, comprehend and record information required in the protocol e.g. complete assessments using an electronic device
- •4.Meets ACR clinical and radiographic criteria for classification of idiopathic (primary) osteoarthritis of the knee as defined by: knee pain and radiographic osteophytes and at least one of the following:
- •i.Age > 50 years
- •ii.Morning stiffness < 30 minutes in duration
- •iii.Crepitus on active motion of the weight-bearing knee
- •5.A diagnosis of primary osteoarthritis of the knee for at least 3 months in symptom duration prior to screen
- •6.Documented anteroposterior radiographic evidence of tibio-femoral osteoarthritis within past 12 months (grade 2 or 3 according to the Kellgren & Lawrence scale)
- •7.American Rheumatism Association (ARA) functional class I, II or III (Appendix 3)
- •8.Has =80 mm for the WOMAC pain subscale question 1 score at screen
- •9.Has =50 mm for the WOMAC pain subscale question 1 score at baseline
- •10.Has a minimum worsening between screen and baseline of 15mm for the WOMAC pain subscale question 1 score
- •11.Has a minimum worsening between screen and baseline of 1 point for the patient global assessment of arthritis condition
- •12.Subject has taken NSAIDs/COX-2 inhibitors for the treatment of their knee OA for at least 5 out of 7 days in each of the 4 weeks preceding screen.
- •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
- •1.Known history of hypersensitivity or intolerance to NSAIDs, aspirin, COX-2 inhibitors, unless subject has subsequently taken at least two separate NSAIDs/COX-2 inhibitors for at least 1 month without reaction. Intolerance of paracetamol/acetominophen. History of aspirin-sensitive asthma or nasal polyps
- •2.Any clinical or biological abnormality found at screen (other than those related to the disease under investigation) which, in the opinion of the investigator, is clinically significant and would preclude safe participation in this study (i.e. current malignancy, human immunodeficiency virus (HIV) infection, significant mental illness)
- •3.History of gastroduodenal perforations and/or obstructions
- •4.History of any gastric or duodenal surgery
- •5.Active gastrointestinal (GI) ulceration of the upper GI tract within the previous 6 months, bleeding of the upper GI tract within the previous year (including hematemesis)
- •6.History of lower GI bleeding (excluding haemorrhoids) within the past year
- •7.History of inflammatory bowel disease
- •8.Use of proton pump inhibitors (e.g., omeprazole, lansoprazole) at any dose for any period longer than 4 consecutive days during the month prior to study start or during the study unless the subject has a history of GI ulceration (> 6 months prior to study start)
- •9.Use of sucralfate or misoprostol
- •10.Use of potent CYP3A4 inhibitors i.e. ritonavir, ketoconazole, itraconazole, saquinavir, nelfinavir, troleandomycin, azithromycin and erythromycin. Other CYP3A4 inhibitors are permitted
- •11.History of coronary artery disease (angina [stable or unstable], myocardial infarction or any coronary artery surgery)
- •12.History of congestive heart failure or renal artery stenosis
- •13.History of stroke or transient ischemic attack
- •14.Uncontrolled (treated or untreated) hypertension at screen (sitting systolic blood pressure [SBP] >160mmHg and/or sitting diastolic blood pressure [DBP] >90mmHg)
- •15.Subjects taking aspirin (including low dose [<325mg per day] for cardiovascular prophylaxis) are excluded; subjects may not discontinue low dose aspirin for the purpose of study participation
- •16.Use of a combination of a diuretic with either an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB). Note that subjects taking only a diuretic, or only an ACE/ARB drug, are not excluded. Examples of agents covered by this criterion are listed in Appendix 4
- •17.Use of anticoagulants (warfarin, heparin) or anti-platelet aggregation agents (including low-dose aspirin) or a condition associated with decreased haemostasis
- •18.Subjects with any one of creatinine, bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 times the upper limit of normal (ULN) at screen are excluded. Subjects with two or more of bilirubin, ALT or AST above the ULN are excluded
- •19.A history of clinically significant drug or alcohol abuse, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria
- •[American Psychiatric Association, 1994]
- •20.Demonstrated allergic-type reactions to sulphonamides (including celecoxib or valdecoxib)
研究者
相似试验
进行中（未招募）
不适用
A Phase III, 12-week, Multicentre, Double-blind, Double-dummy, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group study to investigate the Efficacy and Safety of GW406381 1mg, 5mg, 10mg, 25mg and 50mg administered orally once daily, in adults with Osteoarthritis of the kneeOsteoarthritis of the KneeMedDRA version: 7.1Level: LLTClassification code 10023476EUCTR2005-000149-12-SEGlaxoSmithKline Research & Development Limited1,120
进行中（未招募）
不适用
A Phase III, 12-week, Multicentre, Double-blind, Double-dummy, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group study to investigate the Efficacy and Safety of GW406381 1mg, 5mg, 10mg, 25mg and 50mg administered orally once daily, in adults with Osteoarthritis of the kneeOsteoarthritis of the KneeMedDRA version: 7.1Level: LLTClassification code 10023476EUCTR2005-000149-12-DKGlaxoSmithKline Research & Development Limited1,120
进行中（未招募）
不适用
A Phase III, 12-week, Multicentre, Double-blind, Double-dummy, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group study to investigate the Efficacy and Safety of GW406381 1mg, 5mg, 10mg, 25mg and 50mg administered orally once daily, in adults with Osteoarthritis of the kneeEUCTR2005-000149-12-DEGlaxoSmithKline Research & Development Limited1,120
进行中（未招募）
不适用
A Phase III, 12-week, Multicentre, Double-blind, Double-dummy, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group study to investigate the Efficacy and Safety of GW406381 1mg, 5mg, 10mg, 25mg and 50mg administered orally once daily, in adults with Osteoarthritis of the kneeEUCTR2005-000149-12-HUGlaxoSmithKline Research & Development Limited1,120
进行中（未招募）
不适用
A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid ArthritisMedDRA version: 7.1Level: LLTClassification code 10039073Rheumatoid ArthritisEUCTR2005-000158-61-DEGlaxoSmithKline Research & Development Limited2,210