EUCTR2014-003737-26-Outside-EU/EEA进行中（未招募）不适用
A Phase 4, 6-week, randomized double-blind, multicenter, active-controlled trial to evaluate the effects of Celecoxib (Celebrex®) or Naproxen on blood pressure in paediatric subjects with juvenile idiopathic arthritis
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Inc
- 入组人数
- 201
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.Polyarticular (both rheumatoid factor positive and rheumatoid factor negative), oligoarticular and extended oligoarticular JIA for greater than or equal to (>=) 3 months meeting the International League of Associations for Rheumatology (ILAR) criteria for JIA. Subjects with Systemic JIA with active arthritis in at least 1 joint but without active systemic features are eligible. Subjects with psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis should be excluded.
- •2.>=2 years of age and less than (<) 18 years of age prior to the Baseline visit.
- •3.Body weight >=10 kg at the Baseline visit.
- •4.Candidate for chronic Non-steroidal anti-inflammatory drug (NSAID) therapy in the Investigator’s judgment.
- •5.Females of childbearing potential (defined as menarche or >=10 years of age, whichever occurs sooner) must agree to use adequate contraception (adequate contraception can include abstinence if the Investigator deems appropriate) and must have a negative urine pregnancy test prior to administration of study medication.
- •6.Subject’s parent or legal guardian has provided written informed consent document prior to enrollment in this study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 198
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis types of JIA
- •2.Active systemic features over the prior 12 weeks in children with systemic JIA.
- •3.Subjects taking any of the following medications are specifically excluded:
- •4.Current NSAID or salicylate compounds (must be discontinued more than (>)5 half-lives, or a minimum of 48 hours, whichever is greater, prior to the Baseline Visit).
- •5.Anticoagulants (eg, warfarin, heparin, low molecular weight heparin);
- •Cyclosporine;
- •Tacrolimus (FK 506);
- •Antihypertensives;
- •Any medication in the investigator judgment which will affect the blood pressure;
- •6.Any investigational medication within 30 days prior to Screening or subject is scheduled to receive an investigational drug during the course of this study.
- •7.Initiation of or the change in doses of disease modifying anti-rheumatic drugs
- •8.(DMARDs) and / or Biologics within 30 days of Screening.
- •9.Oral or injectable (including intra-articular) corticosteroids administered within
- •10.2 weeks of Screening/Baseline. Subjects are allowed to continue intranasal or
- •11.orally-inhaled corticosteroids provided they have been at a stable dose for at least 30 days prior to Screening/Baseline and the dose is not expected to change during the duration of the study.
- •12.Known hypersensitivity allergy or hypersensitivity to sulfonamides, COX-2 selective inhibitors (including celecoxib), aspirin or NSAIDS (including naproxen). Subjects who have experienced asthma, urticaria or allergic-type reactions after taking aspirin or other NSAIDs must be excluded.
- •13.Diagnosis of or received treatment for esophageal, gastric, pyloric channel, or
- •14.duodenal ulceration within 60 days of Screening.
- •15.Active GI disease (eg, inflammatory bowel disease, Crohn’s disease, ulcerative
- •16.colitis), a chronic or acute renal or hepatic disorder, a significant coagulation defect, or any condition that in the Investigator’s opinion might preclude the use of an NSAID.
- •17.AST /glutamic oxaloacetate transaminase (SGOT), ALT/Serum glutamic pyruvate transaminase (SGPT), Creatinine or Blood urea nitrogen (BUN) > 1.5* upper limit of normal (ULN) for age/gender-adjusted normal values as per the central laboratory, or any other laboratory abnormality considered by the Investigator to be clinically significant within 14 days prior to Baseline.
- •18.Hypertension defined as Systolic blood pressure(SBP) and/or Diastolic Blood pressure (DBP) values >= 95th percentile for the subject’s age, gender, and height (according to the Fourth Report on the Diagnosis, Evaluation, and Treatment of High Blood Pressure in Children Adolescents for 3 measures at the Baseline visit. If the subject’s medical history indicates that the subject is normotensive, the subjects can be rescreened during the 2-week Screening period to determine if the subject is suitable for the study. Subjects currently treated with antihypertensive medication(s) are not eligible for the study.
- •19.Active malignancy of any type or history of a malignancy. (Subjects with a history of malignancies that have been surgically removed or eradicated by irradiation or chemotherapy and who have no evidence of recurrence in the prior 2 years and at the time of Screening are acceptable).
- •20.Any significant, uncontrolled chronic condition (eg, diabetes, epilepsy, psychiatric disorders), or any other condition which, in the opinion of the Investi
研究者
相似试验
已完成
不适用
A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects-M08M08PER-125-09PFIZER S.A.,10
进行中（未招募）
不适用
A phase IV, 6-week, randomised, double-blind, multicentre, parallel group, comparative study to evaluate the efficacy of rosuvastatin 5 mg and atorvastatin 10 mg in UK Asian subjects with primary hypercholesterolaemia - SHUKRAHypercholesterolaemiaMedDRA version: 8.1Level: LLTClassification code 10020603Term: HypercholesterolaemiaEUCTR2006-003286-14-GBAstraZeneca UK Ltd
进行中（未招募）
不适用
Clinical study to evaluate the efficacy and safety of diclofenac diethylamine 2.32% gel in subjects with knee osteoarthritisMedDRA version: 14.1Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859Knee osteoarthritisEUCTR2012-004024-38-DEovartis Consumer Health S.A.
进行中（未招募）
不适用
A 4-week, multicentre, randomized, double-blind, double-dummy, parallel group ambulatory blood pressure monitoring study to demonstrate that treatment with lumiracoxib 100 mg o.d. results in a 24-hour blood pressure profile superior to ibuprofen 600 mg t.i.d. in OA patients with controlled hypertensioMedDRA version: 8.0Level: LLTClassification code 10031161OsteoarthritisEUCTR2005-003286-17-FIovartis Pharma Services AG1,020
进行中（未招募）
不适用
A 4-week, multicentre, randomized, double-blind, double-dummy, parallel group ambulatory blood pressure monitoring study to demonstrate that treatment with lumiracoxib 100 mg o.d. results in a 24-hour blood pressure profile superior to ibuprofen 600 mg t.i.d. in OA patients with controlled hypertensioMedDRA version: 8.0Level: LLTClassification code 10031161OsteoarthritisEUCTR2005-003286-17-SEovartis Pharma Services AG1,020