临床试验/NCT01399008

NCT01399008已完成2 期

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MBX-102 in Combination With Allopurinol in Gout Patients With an Inadequate Hypouricemic Response to Allopurinol Alone

CymaBay Therapeutics, Inc.0 个研究点目标入组 100 人开始时间: 2011年6月最近更新: 2015年9月18日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: CymaBay Therapeutics, Inc.
入组人数: 100
主要终点: Serum Uric Acid

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the efficacy, safety and tolerability of MBX-102 in combination with allopurinol compared to allopurinol alone when administered orally once a day for four weeks to gout patients with an inadequate hypouricemic response to allopurinol alone.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Known gout patients (per criteria of the American Rheumatism Association for the classification of the acute arthritis of primary gout
•Patients who have been taking at least 200 mg/day of allopurinol as the sole ULT for at least two weeks with a sUA of ≥ 6.5 mg/dL and ≤ 12 mg/dL at screening and ≥ 6.0 mg/dL and ≤ 12 mg/dL at Week -1 (Visit 2) randomization visit.
•Patients who are not on ULT or are taking allopurinol < 200 mg/day must have a sUA ≥ 8.0 mg/dL and ≤ 12 mg/dL at screening and ≥ 6.0 mg/dL and ≤ 12 mg/dL at Week -1 (Visit 2) randomization visit.
•Male or female, 18-75 years of age at screening
•All female patients must be surgically sterile or post-menopausal (at least 45 years of age with no history of menses for at least 2 years; or any age with no history of menses for at least six months and serum FSH ≥ 40 mIU/mL) or have a partner who has undergone vasectomy or must agree to use two medically accepted methods of contraception including a barrier method (see the list in Appendix 4) for the entire duration of the study unless she reports complete sexual abstinence.
•Female patients must not be pregnant or lactating.
•Male patients with a female partner of child-bearing potential must agree to use condoms or the partner must use a medically acceptable method of contraception for the entire duration of the study.
•Estimated creatinine clearance (CrCl) by Cockcroft-Gault method ≥ 60 mL/min at screening
•Serum creatinine value ≤ 1.1 mg/dL in females and ≤ 1.3 mg/dL in males
•Liver function tests ≤ 1.5X ULN for AST, ALT and T-bilirubin, ≤ 2X ULN for ALP, ≤ 3X ULN for GGT; and ≤ 3X ULN for CK
•All other clinical laboratory parameters must be within normal limits or considered not clinically significant for participation in this study.
•Electrocardiogram (ECG) must be normal, or if abnormal, considered not clinically significant for participation in this study.
•Systolic blood pressure ≤ 160 mm Hg and diastolic blood pressure ≤ 90 mm Hg; known hypertensive patients controlled with medications other than thiazide diuretics (blood pressure [BP] reading as above) may be included

排除标准

•Treatment with any ULT other than allopurinol (e.g., probenecid, benzbromarone, febuxostat, or pegloticase) within 30 days of the Screening Visit
•Known or suspected secondary hyperuricemia (e.g. due to myeloproliferative disorder, or organ transplant)
•Diagnosis of xanthinuria
•History of documented or suspected kidney stones
•Known infection with HIV or history of viral hepatitis type B or C
•History of illicit drug or alcohol abuse within 1 year of screening
•History of significant pulmonary disease, upper GI bleeding, documented peptic ulcer disease (unless known H. pylori infection treated successfully without recurrence), or nephrotic syndrome within three years of screening
•History of stroke, TIA, acute MI, congestive heart failure (NYHA Class II-IV), angina pectoris, coronary intervention procedure (including but not limited to angioplasty, stent placement, coronary revascularization), lower extremity bypass procedure, systemic or intracoronary fibrinolytic therapy within five years of screening
•Malignancy (except treated basal cell carcinoma) within five years of screening
•BMI > 42 kg/m2
•Current or expected requirement for anticoagulant therapy (except for aspirin ≤ 325 mg/day)
•Rheumatoid arthritis or other autoimmune disease requiring ongoing treatment
•Current or expected treatment with potent CYP3A4 inhibitors (See Appendix 6), cytotoxic agents (azathioprine, mercaptopurine, cyclosporine, cyclophosphamide, etc.), ranolazine, digoxin, theophylline, sulphonylureas, thiazolidinediones, diuretics, atypical antipsychotic agents, ampicillin, amoxicillin or phenytoin
•Chronic treatment with NSAIDs (use to treat acute flares are permitted).
•Current or expected treatment with systemic corticosteroids (except topical, ophthalmic, intra-articular, or inhaled at a dose < 1600 μg/day) other than to treat acute flare
•Known hypersensitivity to allopurinol, colchicine, or aspirin
•Treatment with any other investigational therapy within the 30 days prior to screening, or patients who received at least one dose of study drug while enrolled in any previous or concomitant MBX-102 trial
•Any other condition that compromises the ability of the patient to provide informed consent or to comply with the objectives and procedures of this protocol, as judged by the investigator and/or medical monitor.

研究组 & 干预措施

Arhalofenate 400 mg

Experimental

Arhalofenate 400 mg plus allopurinol 300 mg

干预措施: Arhalofenate (Drug)

Arhalofenate 400 mg

Experimental

Arhalofenate 400 mg plus allopurinol 300 mg

干预措施: Allopurinol (Drug)

Arhalofenate 400 mg

Experimental

Arhalofenate 400 mg plus allopurinol 300 mg

干预措施: Colchicine (Drug)

Arhalofenate 600 mg

Experimental

Arhalofenate 600 mg plus allopurinol 300 mg

干预措施: Arhalofenate (Drug)

Arhalofenate 600 mg

Experimental

Arhalofenate 600 mg plus allopurinol 300 mg

干预措施: Allopurinol (Drug)

Arhalofenate 600 mg

Experimental

Arhalofenate 600 mg plus allopurinol 300 mg

干预措施: Colchicine (Drug)

Allopurinol

Active Comparator

Placebo plus Allopurinol 300 mg

干预措施: Allopurinol (Drug)

Allopurinol

Active Comparator

Placebo plus Allopurinol 300 mg

干预措施: Colchicine (Drug)

Allopurinol

Active Comparator

Placebo plus Allopurinol 300 mg

干预措施: Placebo (Drug)

结局指标

主要结局

Serum Uric Acid

时间窗: Percent change from baseline in serum uric acid at Week 4

Percent change from baseline in serum uric acid in Per Protocol population

次要结局

未报告次要终点

研究者

发起方

CymaBay Therapeutics, Inc.

申办方类型

Industry

责任方

Sponsor

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